International regulatory news in brief

This post covers international regulatory news in brief. It will be updated on an ad hoc basis.

For ease of navigation, a tab has been added for each region (below). Click on the respective tab to view the news for that region.

The latest updated section(s) are:

  • Rest of Europe (Switzerland) – 1 July
  • Oceania (New Zealand) – 1 July
  • Oceania (Australia) – 30 June
  • EU (European Medicines Agency) – 28 June
  • Medical devices (Australia) – 27 June
  • Oceania (Australia) – 27 June
  • Rest of Europe (UK) – 24 June
Switzerland
1 July
Revision of the Therapeutic Products Licensing Requirements Ordinance – Update to Annex 7 TPLRO

At a meeting of Swissmedic’s Agency Council on 22 April 2022 following the conclusion of the consultative process involving subject-matter experts and official bodies, it was decided that Annex 7 TPLRO should be amended with effect from 1 July 2022.

In addition to clarifications of conditions and documentation requirements, the current revision of Annex 7 TPLRO also includes a new quality change for Type II. This concerns B.I.a.5 b): Changes associated with changes to the active substance of a human SARS-CoV-2 vaccine, including the replacement or addition of a serotype, strain, antigen or coding sequence or a combination of serotypes, strains, antigens or coding sequences. The EMA has incorporated a similar amendment in its catalogue of variations.

The form Variations and extensions HMP HMV4 has been amended accordingly on this basis.

Source: Swissmedic

14 June
First application reviewed by all five Access Consortium regulatory authorities in the Access Consortium “New Active Substance Work Sharing Initiative” (NASWSI)

On 25 May 2022, Swissmedic, in cooperation with its partner authorities Health Canada (HC), Health Sciences Authority (HSA) Singapore, the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom and Australia’s Therapeutic Goods Administration (TGA) in the Access Consortium “New Active Substance Work Sharing Initiative” (NASWSI), authorised the medicinal product Vabysmo® (active substance: faricimab), solution for injection for intravitreal use for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and for the treatment of diabetic macular oedema (DME).

This was the first application reviewed by all five Access authorities. The principal review activities were divided up as follows:

  • Module 3 Drug Substance: HSA,
  • Module 3 Drug Product: Swissmedic,
  • Module 4: TGA,
  • Module 5: HC and MHRA.

In addition, all modules were subjected to peer review. A consolidated List of Questions was sent to the marketing authorisation holder and timelines were synchronised except for the national labelling phase. The decision as to whether to authorise the medicinal product was taken independently by each authority after the review.

Swissmedic granted authorisation for faricimab after a review period of 212 days only.

Source: Swissmedic

4 May
Technical requirements for the submission of clinical trial applications for medicinal products

To complement the various documents that Swissmedic has published summarising the technical requirements for the submission of applications for clinical trials for medicinal products, a Q&A document with the most frequently asked questions has also been published. This Q&A document aims to answer the most important questions connected with the submission of applications and documents for clinical trials. It should always be read in conjunction with the Guidance on the new submission process. Both documents can be accessed here.

Source: Swissmedic

1 May
Clarifications on the prioritisation and fast-tracking of pandemic medicinal products and on the patient information requirements

Swissmedic will continue to prioritise authorisation applications for medicinal products used to prevent and treat a pandemic disease (e.g. COVID-19) and fast-track these according to the pandemic situation so that safe and effective medicines can be made available to patients as quickly as possible.

If authorisation applications for pandemic medicinal products are to be assessed in line with the official time limits for the fast-track or temporary authorisation procedure (in accordance with the guidance document Time limits for authorisation applications HMV4), the corresponding requests must be made before the application is submitted. These requests will also be given priority and fast-tracked in line with the pandemic situation.

As a further clarification, Swissmedic states that patient information (if available) for pandemic medicinal products must also be provided in the official languages as set out in Art. 26 para. 2 TPO.

The revised guidance document entitled Authorisation procedures for Covid-19 medicinal products during a pandemic HMV4 available at the link below is valid with effect from 1 May 2022.

Source: Swissmedic

1 April
Update to Guidance document “Information on PSUR / PBRER submission”

The updated guidance document is avialable on this page. It enters into force on 1 April 2022 with a transitional period of 30 days.

The following points have been expanded on or clarified in section 5.2:

  • PSURs are generally submitted once a year as a 12-month report. It is possible to modify the submission cycle (e.g. submission every 6 months, submission every 2 years).
  • In future, modification of the reporting period will be via notification with brief supporting information (not an application as previously) by the marketing authorisation holder to riskmanagement@swissmedic.ch
  • As a general rule, only one PSUR/PBRER document will be accepted per application.

Clarifications in section 5.4 regarding submission of RMP Updates have also been expanded on.

Source: Swissmedic

UK
24 June
Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending

With reference to the above, the MHRA has added a section on ‘Guidance for The Conversion of PLGB or PLNI licences to PL’

The scope of this guidance excludes products which are:

  • Already the subject of an EU Community Marketing authorisation in Northern Ireland
  • Fall within the mandatory scope of the EMA’s centralised procedure

Therefore, this process does not apply to any GB marketing authorisation that has been approved through the European Community Decision Recognition Procedure (ECDRP) or those that are converted EU Marketing authorisations (so-called grandfathered products).

Information is provided on the following types of conversion:

  • Amending of Great Britain Licence (PLGB) or Northern Ireland Licence (PLNI) to a UK wide PL Licence
  • For Initial applications  that have not yet been approved
  • For approved marketing authorisations

Source: MHRA

19 May
Update to notifying the MHRA about a clinical investigation for a medical device

With reference to the above, The MHRA has updated its website to include a section on what must b done upon identifying study deviations.

Source: MHRA

17 May
MHRA grants first authorisation via the Access Consortium ‘New Active Substance Work Sharing Initiative’

Vabysmo (faricimab) is the first treatment approved by the UK regulator that has been made possible through the Access Consortium ‘New Active Substance Work Sharing Initiative’.

Vabysmo is a new medicine for people with the progressive eye diseases wet age-related macular degeneration (wet AMD) and visual impairment due to diabetic macular oedema (DMO).

You can read more about the Access Consortium ‘New Active Substance Work Sharing Initiative’ in this post.

Source: MHRA

14 April
Sunset clause – notification date

The MHRA has updated its website with the sentence ‘Additional information regarding notification date for changes added’. As no further information has been provided, it is unclear exactly what additional information has been added.

Under the sunset clause, Marketing authorisation (MA) owners must notify the MHRA:

  • when they intend to market a medicinal product so that that the MHRAs records are up-to-date.
  • if the medicinal product is temporarily or permanently taken off the market.

The MA for a product will no longer be valid if it hasn’t been placed on the market for 3 consecutive years. The time left to place a medicinal product on the market will be inherited by the new owner. See the interpretation of the directive document for more detailed information.

  • The notification date for changes of marketing status should be made as close to the actual date to avoid multiple notifications of the same change of marketing of the product.
  • The timelines for requests for exemptions to the Sunset Clause should follow the same timelines as the changes to marketing.
  • Please continue to notify DHSC to the timelines that they have suggested as these updates are required for future planning of supply contracts.
  • Retrospective exemption requests can not be made after the product expires under Sunset Clause.

Source: MHRA

16 March
Importing medicines into Northern Ireland

The EU published a Communication to the Commission on the 17th Dec 2021, on the Approval of the content of a Draft Commission Notice on the application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the UK other than Northern Ireland, and associated updates to Directives 2001/20/EC, 2001/83/EC, regulation 536/2014 and delegated regulation 2016/161.

This communication extends the derogation first published in the EU Commission notice of the 25 January 2021 and sets out a reporting obligation on industry to notify the MHRA for medicines imported into Northern Ireland as described.

Products approved in the UK before 31 January 2021

For products approved in the UK before 31 January 2021, the EU Commission Notice means that, for all UK licenced medicines within a company’s portfolio, companies will seek to make use of these flexibilities unless the MHRA is directly informed otherwise. This will be the basis for MHRA enforcement.

The justifiable reason for using the flexibilities exists where each batch is released by a QP on an EU site, or a UK site demonstrating equivalent standards; and that the establishment is supervised. This is to ensure continued supply to Northern Ireland.

You only need to notify the MHRA if you no longer plan to apply these flexibilities to the products in your company’s portfolio.

For each medicine, you should provide:

  • product name
  • marketing authorisation number
  • strength/pack size
  • the reason why flexibilities are not required

Products approved in the UK after 31 January 2021

For products approved in the UK after 31 January 2021, the EU Commission Notice means that these flexibilities apply to all new products and you only need to notify the MHRA if you do not plan to make use of the flexibilities. This will be the basis for MHRA enforcement.

The justifiable reason for using the flexibilities exists where each batch is released by a QP (Qualified Person) on an EU site or UK site demonstrating equivalent standards; and that the establishment is supervised. This is to enable industry to use existing manufacturing and supply chain logistics while the necessary changes are made to ensure continued supply to NI.

You should email info@mhra.gov.uk providing details (the same details as bulleted above) of each medicine which will not make use of these flexibilities.

For new product applications via the decentralised procedure (DCP) or mutual recognition procedure (MRP) with UK(NI) as a Concerned Member State (CMS)

In this case, the regulatory flexibilities as set out in the EU Commission Notice permit each batch of medicinal product to be tested and released by a QP on a site in the UK.

Medicines Supply to Northern Ireland

A Medicines Supply for Northern Ireland webinar took place on Wednesday 2 and Thursday 3 February 2022 and is available here.

Source: MHRA

 

European Medicines Agency
28 June
Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability

In line with Regulation (EU) 2022/123, Marketing authorisation holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’ 

The i-SPOC will facilitate rapid communication between EMA and MAHs to detect, report, and prevent or manage supply and availability issues of medicines included in a list of critical medicines for a ‘public health emergency’ or a ‘major event’. The Agency recently published the first list of critical medicines for the management of the COVID-19 pandemic.

Registration of an i-SPOC is a two-step process which may take up to 5-10 working days. EMA has updated the PDF icon IRIS user guide  and published a video demo to support companies with the registration process.

Companies must register their i-SPOC in EMA’s IRIS online platform by 2 September 2022.

Here is a link to an EMA webinar from 28 June 2022 where further information is provided on the above, between 1 hr 7 min to 1 hr 13 mins into the presentation.

Source: EMA

9 June
Compilation of QRD decisions on stylistic matters in product information

Rev 22 of this document dated 7 June is a available here.

Changes since the last revision include:

  • Inclusion of new guidance for ‘Direct speech’
  • ‘Drug’, and ‘Multilingual packaging: impact on Annex IIIA’
  • Revised guidance for ‘INN translation (BE examples and PL requirement)’
  • ‘Numbers separators’
  • ‘Unit dose pack sizes (DE and MT translations)’
  • ‘Units: SI base units – litre (EL, EN and MT requirements)’, and
  • ‘Use of English or Latin (CS requirement)’.

Source: Europa website

Using the Organisation Management Service (OMS) – upcoming EMA webinars

The EMA integrated the Organisation Management Service (OMS) with the EudraGMDP database on 28 January 2022. Manufacturers and wholesalers must now ensure that the following details are registered in OMS:

  • organisation name;
  • authorised site address for MIA and WDA holder;
  • address(es) where manufacturing and wholesaling activities take place.
5 April
IRIS guide for applicants

The IRIS guide for applicants on How to create and submit scientific applications, for industry and individual applicants has been updated. The latest version 2.7 of 31 March 2022 is available here.

Source: European Medicines Agency

European Commission
20 June
Summary record: Pharmaceutical committee 11 May 2022 99th meeting

The following items were included in the above meeting:

Scope of the pharmaceutical legislation

  • Discussions covered the legal provision defining ‘pharmaceutical product’ and the scope of the legislation (inclusions / exceptions).
  • Special consideration was given to the term ‘industrial process’ and whether its inclusion or not in the scope can help in regulating new technologies such as personalised medicines, decentralised manufacturing but without extending the scope of the legislation to cover non-pharmaceutical products.
  • Member States mostly agreed that the definitions in legislation should be reviewed as they need to be future-proof. It was also pointed out that flexibility should be built-in the legislation to allow for adaptations of the definition to the rapid changes in science and technology.
  • They also highlighted that the review should contribute to clarity and predictability and to support innovation and patient access.
  • However, some experts highlighted the risks inherent to the qualification of borderline products and called for a procedure to solve rapidly such issues (e.g. use a committee to receive a harmonized opinion on whether the product is within the scope of medicinal regulations and if not on how to assess).

Scope of the centralised application procedure

  • The first question examined the possibility of exclusion of generic applications from the centralised procedure to allow the CHMP to focus on more complex and innovative applications.
  • While some Member States maintain that applicants should have the choice between the national and centralized procedures and some other Member States agree to the transfer to national level, other Member States agreed to a more nuanced approach e.g. transferring the simple generics to the Member States (MRP/DCP procedures) and keep the complex generics with the centralized procedure.
  • The second question pertained to medicines containing or consisting of elements deriving from nanotechnology and its applications (popularly also known as ‘nanomedicines’). These are complex to manufacture but offer numerous advantages.
  • The Committee discussed whether such medicines should always be approved under the centralised procedure, especially since many of the early ‘nanomedicines’ are coming off patent and their off patent counterparts come to the market there is a call for harmonised assessment of these products by different Member States.
  • Even though Member States thought that a definition and harmonised criteria for assessing such products can be useful (including through guidelines) there is currently no apparent need for a special pathway or to include them in the mandatory scope of the CAP.
  • Members of the Committee maintained that the current rules sufficiently guarantee the main principles of the assessment process including for these medicinal products.

Product Information

  • As regards electronic product information members of the Committee agreed that adding the possibility to provide product information by means other than the printed packages and leaflets is an important tool to deliver on access, availability and futureproofing of legislation.
  • Members of the Committee were open to a stepwise approach to allow such possibilities in a first phase for specific categories of products (such as medicines administered by a healthcare professional, or used in hospitals) or to leave the final choice on the use of electronic product information to each Member State.
  • Moreover, it was proposed that in principle for over the counter medicines, medicines sold in some geographical areas, patient categories and exceptional situations (blackouts, crises) paper should continue to be present to ensure the appropriate use of medicines. It was also mentioned that changes in this regard should not transfer the costs to patients and health systems.

Pharmacovigilance

  • The point covered medicines which are subject to additional monitoring. They are identified by the inclusion of a ‘black symbol’ (a black inverted triangle) in the product information and an explanatory statement in the product information.
  • The aim was to discuss with Member States whether this legal provision should be revised. Most Member States supported the elimination of the measure and its replacement with pharmacovigilance actions outside legislation stressing that the general pharmacovigilance requirements in the legislation are working well and that the black triangle has not proved its effectiveness.
  • Some Member States suggested that the additional monitoring status should be kept but limited in scope and based on “an active substance” and not “the product” as it is now in order to avoid situation that generics do not have the black triangle.

Source: Europa website

7 June
Complex Clinical Trials Q & A

A 29 page Q&A on complex clinical trials has been published on the European Commission website. You can download it here.

The Q&A document provides guidance and seeks to support sponsors, clinical trialists and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT authorisation (CTA), conduct, reporting and transparency, analysis and interpretation of complex clinical trials (CCTs) under the EU Clinical Trials Regulation (EU CTR) as well as their use in submissions for marketing authorisation. It complements and should be used together with relevant EU and ICH guidelines, in particular E6, E8, E9, E10, E16, E19, E11A and E20 (when available).

Ireland
15 June
HPRA Medicinal Products Newsletter Issue 71

HPRA has published Issue 71 of its newsletter packed with information.

Included in this issue is information on the following topics topics:

  • Brexit – products availing of a derogation under Directive 2022/642/EC
  • Clinical Trials Regulation

Source: HPRA

14 June
Request for a derogation under Directive 2022/642

Due to the historical dependence of Ireland (IE), Malta, Cyprus and Northern Ireland on medicines supplied from or through parts of the UK other than Northern Ireland and with the aim of preventing shortages of medicines and ensuring a high level of public health protection with regard to medicinal products for human use, the Commission adopted legislative proposals amending Directive 2001/83/EC, Directive 2001/20/EC and Regulation (EU) 536/2014 by way of Directive 2022/642/EC and Regulation (EU) 2022/641.

This permits the HPRA to apply certain derogations to facilitate supply of medicinal product to the Irish market. The permitted derogations applicable to Ireland are outlined in Directive 2022/642/EC and Regulation (EU) 2022/641, and are subject to certain conditions.

  • Approval of derogation requests will be primarily based on the information provided and the conditions agreed to by the applicant in this form, which should be carefully completed.
  • Applicants should ensure the information provided here is in line with the information provided in the ‘Directive 2022/642: Justifiable case template for inclusion or retention of UK(GB) sites in regulatory submissions for Ireland‘ form (submitted at time of validation of an MR/DCP variation, renewal or new application; however, the granting of this derogation will be based on the information provided in this request.
  • Derogations may be refused, notwithstanding a previous acceptance of a justifiable case template for the purposes of validation by the HPRA or other Member States.
  • Acceptance by the HPRA of any requests for derogations applies only to medicinal products supplied to the Irish market or to investigational medicinal products provided in clinical trials approved in Ireland.
  • The derogations are limited in time and will maximally apply as stipulated in Directive 2022/642/EC and Regulation (EU) 2022/641.

Section A must be completed for all requests and Section B (including subsections and associated condition sections) for the specific derogations that are requested. All derogation requests relating to a product should be contained within the same form. 

Further information on products availing of a derogation under Directive 2022/642/EC is available in the HPRA Medicinal Products Newsletter Issue 71.

Source: HPRA

9 June
New SUSAR form for investigator led trials

The suspected unexpected serious adverse reaction report (SUSAR) form for investigator led trials can be downloaded here.

Source: HPRA

30 May
Derogation under Directive 2022/642/EC (post-Brexit)

On 20 April 2022, Directive 2022/642/EC of the European Parliament entered into force. It amends Directives 2001/20/EC and 2001/83/EC regarding derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of:

  • Northern Ireland
  • Cyprus
  • Ireland
  • Malta

The objectives of amending Directive 2022/642/EC are to facilitate continued supply of medicinal products and to maintain a high level of public health protection. In order to ensure uniform application of Union law in all Member States, the derogations applicable in Cyprus, Ireland and Malta will apply until 31 December 2024.

To ensure transparency, the Directive stipulates that the competent authorities of Cyprus, Ireland and Malta and the United Kingdom in respect of Northern Ireland publish on their website a list of the medicinal products marketed to which these derogations have been granted.

The HPRA has compiled the list of products availing of the derogations as permitted in Directive 2022/642/EC. Products are identified by product name, PA number and MAH. This list is required to be updated on at least a six-monthly basis.

MAHs to whom derogations have been granted are required to check the details of this list below and to contact the HPRA at brexit@hpra.ie when a particular derogation is no longer required, specifying which derogation is no longer needed. When full regulatory compliance has been achieved, please contact the HPRA and the product can be removed from the list.

Source: HPRA

29 April
Guide to Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland

This guide has been updated from the version the version AUT-G0170-2 to the version AUT-G0170-3 of 29 APRIL 2022.

There appears to be only one minor change throughout the document, at the end of the first paragraph in section 3.13 Fees. Here, you can view the track changed and clean versions of the document.

13 April
Improvements to the process of issuing new licences via the use of Article 61(3) submissions

The HPRA has simplified the procedure for reviewing labelling mock-ups in order to accelerate the issuing of licences for new products and to provide greater predictability for applicants planning product launches. The improvements should help help to facilitate the timely availability of new medicines for patients.

In the new procedure, only the following aspects concerning labelling mock-ups are reviewed:

  • layout
  • design
  • readability

This allows the early submission of these mock-ups using an Article 61 (3) notification. As a result of this change, companies can submit the Article 61 (3) notification with the proposed labelling mock-ups at any time during the new application procedure. This facilitates the Article 61 (3) notification being reviewed in advance and approved at the same time as the new licence approval or allows a licence to issue while finalising mock-ups prior to marketing.

It is not required to resubmit amended labelling mock-ups if the labelling text changes during the new application procedure after the submission of the Article 61(3) if there have been no consequential design changes.

Additionaly, the HPRA reaffirms that it is the responsibility of the applicant to ensure that the final publishable versions of the national SmPC and package leaflet submitted to the HPRA based on the end of procedure texts are correct. The HPRA will not re-check these documents before publication on the HPRA website.

The HPRA will monitor the effectiveness of the changes to the process and will continue engaging with applicants to ensure the intended benefits are delivered.

Source: HPRA

Italy
7 June
Launch of the new National Pharmacovigilance Network (RNF), a new online platform to report ADRs

On 20 June 2022, the new National Pharmacovigilance Network (RNF), the system for the collection of suspected adverse drug reactions (ADRs) reports, managed and analysed in Italy, will go live.

  • The new RNF will feature advanced functions for the management and analysis of reports of suspected adverse reactions in order to ensure an increasingly accurate assessment of the safety profile of medicines.
  • Also new is a new international standardised format for reporting suspected adverse drug reactions, which, will have to be used from 30 June 2022 in all EU countries to send and receive reports of suspected adverse reactions to and from the EudraVigilance System, the European database of suspected adverse drug reactions, with which the RNF is closely linked.
  • From 20 June 2022 the new online reporting method, RNF will also be operational, directly through the AIFA portal, which will replace the current ‘Vigifarmaco’ website In particular, the ‘Vigifarmaco’ site which will be permanently deactivated at 6 p.m. on 8 June 2022.
  • From 9 June to 20 June 2022, there will be a transition period when healthcare professionals and patients/citizens will be able to submit reports of suspected adverse reactions via the current reporting methods i.e.
    • filling in the suspected adverse reaction report form and sending it by e-mail to the Pharmacovigilance Officer of their facility;
    • completing the Suspected Adverse Reaction Report Form and sending it by e-mail to the Marketing Authorisation Holder (MAH) of the medicinal product suspected of causing the adverse reaction.

Source: AIFA

13 May
Updated submission modalities of Active Substance Master Files and subsequent amendments/updates

The Active Substance Master File (ASMF) is a document that the manufacturer of the active substance is required to submit to AIFA in relation to the active substances contained in the medicinal products for which a marketing authorisation application is submitted.

As of 1 June 2022, MAHs will be required to submit ASMFs and relevant updates to the Marketing Authorisation Office as follows:  

  • use of the electronic Common Technical Document (eCTD) to organise the content of the ASMF into modules, sections and documents (further information is available at http://esubmission.ema.europa.eu/ectd/
  • submission of the dossier and subsequent updates through the Common European Submission Portal (CESP). To register: https://cespportal.hma.eu/Account/Register  
  • confirmation of the successful submission to CESP by sending an e-mail to: asmf@aifa.gov.it. In the subject of the e-mail, the following should be specified: MAH, active substance, type of submission, CESP submission ID.

During the transition to the eCTD format, the submission of the documentation in paper format will be considered acceptable until 30 October 2022 at the latest.

Source: AIFA

7 April
Updated submission guidance on application for variatons, renewals, MA transfer, and changes purusant to Article 61(3) and 62 of Directive 2001/83/EC following the end of the Covid-19 emergency (as of 1 April 2022) in Italy

AIFA has provided similar guidance for the above application types as it did for new marketing authorisations and line extensions (see post below of 31 March 2022). You can view the guidance at the links below:

Source: AIFA

Medicines for Europe
Factsheet – The Bolar exemption

Medicines for Europe has published a useful factsheet which details the Bolar exemption, introduced in Europe in Article 10(6) of the Directive 2001/83/EC.

The Bolar exemption allows companies, during the patent/Supplementary Protection Certificate (SPC) protection of the reference product, to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for generic and biosimilar medicines, without this being considered patent/SPC infringement. The Bolar
also exempts from infringement, certain experimental research activities to develop new medicines.

Source: Medicines for Europe

India
6 May
Special conditions under which the permission of import of drug product with residual shelf-life of less than 60% is allowed (due to the pandemic)

The above permission has been been extended until 31 October 2022. The original permission can be viewed on this page.

Singapore
29 April
Regulatory Updates for Therapeutic Product Registration

As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in its regulatory requirements and processes, the Therapeutic Products Branch (TPB), Health Products Regulation Group, has implemented revisions to the Guidance on Therapeutic Product Registration, effective 29 Apr 2022.

1.    Revised checklists for post-approval minor variations (MIV-1 and MIV-2)

The list of changes under post-approval minor variations MIV-2 Do-And-Tell has been expanded, with the re-categorisation of a list of chemistry, manufacturing & controls (CMC) variations from MIV-2 Notification to Do-And-Tell, and the introduction of new Do-And-Tell checklists. The MIV-1 checklists have also been revised to reflect the new changes, as well as to clarify the eligible conditions and documentary requirements.

The expansion of the Do-And-Tell changes aims to reduce the regulatory submission burden and enable timely implementation of administrative and minor CMC changes that do not have any impact on a product’s safety, efficacy and quality.

a) Re-categorisation from MIV-2 Notification to MIV-2 Do-And-Tell

Drug substance

  • Change in batch size of drug substance (DS) within 10‐fold of currently approved batch size
  • Tightening of DS specification limits or in-process tests of limits (IPC) of DS

Drug product and excipients

  • Minor change in the manufacturing process for drug product (DP)
  • Tightening of DP specification limits or IPC of DP

b) New checklists under MIV-2 Do-And-Tell

Expansion of the “Change of release shelf-life specification to comply with latest compendium” checklist to three separate checklists:

  • Change of specification of drug substance to comply with latest compendium
  • Change of specification of drug product to comply with latest compendium
  • Change of specification of excipient or drug substance starting material to comply with latest compendium

c) New checklists under MIV-1

  • Widening of specification limits of IPC or deletion of test parameters and limits of IPC of DP
  • Widening of specification limits and deletion of significant test parameter of excipients

d) Other changes

  • Expansion of scope of product labelling change under Do-And-Tell
  • Inclusion of requirements for submission of electronic format of Drug Master File (DMF) prior to the submission of MIV-1 applications supported by DMF (Refer to the B1, B3 checklists of Appendix 13)

The expansion of the Do-And-Tell changes aims to reduce regulatory submission burden and enable timely implementation of administrative and minor CMC changes that do not have any impact on the product’s safety, efficacy and quality.

You can view the full list of changes here.

2.    Extension of verification evaluation route to biological products, including biosimilar products

The verification evaluation route has been extended to biological products, including biosimilar products, to enable greater leveraging of reference agencies’ assessments and minimise duplication of effort. The eligibility criteria for this route has been updated accordingly in main guidance (Sections 14.3, 24.1).

3.    Other updates

a)    Biosimilar product applications

The guidance in Appendix 15 has been incorporated into Chapter E of the main Guide to provide a consolidated guidance document on the registration of biosimilar products. With this, Appendix 15 has been made obsolete.

b)    Minor/ editorial amendments to the following appendices

  • Patent declaration forms (Appendix 1)
  • Application checklists (Appendices 2A and 3A)

c)    Editorial updates to the following guidance documents:

  • Change of registrant for registered therapeutic product
  • Retention of therapeutic product on the product register

You can view the full list of changes here.

The updated guidance documents may be accessed here.

Source: HSA singapore

Australia
1 July
Compliance with 2021 Therapeutic Goods Advertising Code required from 1 July
Guidance on applying the Advertising Code rules

The 2021 Therapeutic Goods Advertising Code came into effect on 1 January 2022. There was a 6 month period for advertisers to transition their material to the new amended rules where both the 2018 and 2021 Codes applied. The six month period ended on 30 June.
From 1 July 2022, advertisers are required to comply with the 2021 Code. Guidance on applying the Advertising Code rules is available here.
Further information on the The Therapeutic Goods Advertising Code is available here.

Source: TGA

30 June
New version of Uniform recall procedure for therapeutic goods (URPTG) implemented

A new version, V2.3 of the Uniform Recall Procedure for Therapeutic Goods (URPTG) (V2.3, June 2022) has been implemented, effective from 30 June 2022.

The purpose of the URPTG is to assist the sponsors of therapeutic goods to conduct recalls and non-recall actions using a standardised systematic procedure.

The guidance on the Uniform Recall Procedure for Therapeutic Goods (URPTG) provides a consistent approach for undertaking recall and non-recall actions of therapeutic goods supplied, imported into or exported from Australia.

This version includes the following updates:

  1. Removal of the references to the Crisis Management Guidelines
  2. Clarification on the submission of customer/distribution lists, including an example list in the appropriate format
  3. Additional guidance related to the online notification of actions through the TGA Business Services (TBS) website.
  4. Clarification on the submission of final reports, including additional guidance regarding root cause, CAPA information, customer follow-up attempts, and TGA close out letters
  5. Minor changes to the information on consumer recall notices, including targeted SMS alerts and clarification on website publication timeframes

Source: TGA

27 June
Fees and charges: summary from 1 July 2022 and important annual charge deadlines.

The TGA has published its Fees and charges from 1 July 2022

This guidance is a summary of fees and charges, which are in the Australian therapeutic goods legislation. This is not an exhaustive list.

For a complete list of all fees and charges and the exact legislative wording, please refer directly to the legislation.

Also provided is information on important annual charge deadlines.

Source: TGA

8 June
The transition period from the 2018 to the 2021 Advertising Code ends 30 June 2022

The Therapeutic Goods Advertising Code 2021 came into effect on 1 January 2022. The 6 month transition period to the new Code ends on 30 June 2022.

On 1 July 2022 the option of complying with the 2018 Code no longer applies. It is important to ensure that all advertising, including on social media, is compliant by this date.

Source: TGA

TGA launches new beta version of the DAEN database

The TGA has launched a new beta version of the Database of Adverse Event Notifications (DAEN) .

  • The upgraded version allows users to search, view results and interact with the data, both on desktop and mobile devices more easily.
  • It enables users to interact with search results through dynamic tables, filters and graphs. Search results can also be extracted and saved in .csv and .xlsx formats.
  • The beta version is available on the TGA website, alongside the older database.
  • Assuming a successful trial, TGA is planning to switch over to the improved version in 3-4 months.

Source: TGA

New Zealand
1 July

New Medicine Application – Prescription Medicine Form 

A new form applicable from 1 July 2022 for the above application type is is available for for download, here.

Source: Medsafe

13 May
Review of Fees payable under the Medicines Act 1981

Following a consultation in 2021 when Medsafe released a document proposing to increase the fees payable under the Medicines Act 1981 (the Act), it has published a 24 page document with information on the following:

  • Summary of submission responses to the consultation of 2021 and Medsafe response
  • Outome of the consultation which include the following:
    • Decision on fee increases
    • Changes made following consultation
    • Chages required to the Medicines regulations
  • Implementation fo the fee increases

The implementation date is of the fee increases 1 July 2022.

Source: Medsafe

24 April
Minor Guidelines update: Part 4: Manufacture of Medicines

Edition 2 of February 2022 of the above guide has now been published and includes the following minor changes of note:

  • Added requirement for GMP for API that are prescription medicines.
  • Added requirement for ongoing evidence of current GMP compliance to be provided.
  • Removed reference to Part 5 of NZRGM

Source: Medsafe

Australia
5 April
Transitioning to the new Therapeutic Goods Advertising Code

The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (2021 Code) came into effect on 1 January 2022. The 2021 Code repeals and replaces the 2018 Code. A transition period applies until 30 June 2022 during which time advertisers can comply with either the 2021 Code or the 2018 Code.

The mandatory statement requirements in the 2021 Code have been simplified and reduced in number compared with the 2018 Code. The TGA recognises however, that advertisers may hold stock of hard copy advertisements that meet the mandatory statement requirements of the 2018 Code but that are not strictly compliant with the 2021 Code.

  • While advertisers use up their stocks of existing hard copy advertisements the TGA will adopt a pragmatic approach and will not seek to take enforcement action where advertisers comply with the requirements for mandatory statements in the 2018 Code, rather than the 2021 Code.
  • For advertisements that can be readily amended, such as advertisements online and in social media, the TGA expects advertisers to transition to the 2021 Code requirements by the end of the transition period on 30 June 2022.

Source: TGA

1 April
Building a more robust medicine supply: proposals to help prevent, mitigate and manage medicine shortages

In 2021, the TGA conducted a public consultation to seek feedback on reforms intended to help ensure ongoing, reliable supply of important medicines in Australia. We specifically sought feedback on four proposals as possible medicine shortage mitigation or management strategies that would:

  • prioritise the evaluation and registration process for certain important generic prescription medicines, to reduce the risk of shortages
  • encourage registration of more generic versions of medicines known to be affected by shortages, to mitigate the impact of those shortages
  • support a more reliable supply of overseas-registered medicines imported into Australia as substitutes when the Australian medicine is in longstanding or repeated shortage.

In response to the consultation feedback, and the changed regulatory environment the TGA has decided to:

  • initiate amendments to the Therapeutic Goods Act 1989 which would support import of overseas substitute medicines if the Australian medicine has been discontinued and cancelled from the ARTG.
  • address barriers to registration by creating a web-based information hub to assist sponsors, including those less experienced in registration of prescription medicines that are subject to, or vulnerable to shortage. The hub will feature access to individual pre-submission advice such as early scientific advice.
  • will prioritise the start of evaluation for registration applications that are identified to prevent or address a medicine shortage if it is in the interest of public health.

Source: TGA

30 March
Updates to legislative instruments exempting monographs as standards

TGA has updated legislative instruments specifying that certain monographs of the United States Pharmacopeia-National Formulary (USP) are not accepted as default standards.

These instruments were due to sunset on 1 April 2022, providing TGA with the opportunity to review requirements.

i) Remade legislative instrument: Therapeutic Goods (Standard for Human Albumin) (TGO 111) Order 2022

The TGA has remade Therapeutic Goods Order No. 90 Standard for human albumin (TGO 90), as the Therapeutic Goods (Standard for Human Albumin) (TGO 111) Order 2022 with no technical amendments.

TGO 111 commences on 31 March 2022 and continues to specify that albumin from humans must comply with the monograph for human albumin in the British Pharmacopoeia (BP) or the European Pharmacopoeia (Ph. Eur.). The USP monograph for human albumin is not accepted as a default standard. TGO 111 reflects the requirements of TGO 90 and is not intended to alter existing arrangements.

ii) Updated legislative instrument: Therapeutic Goods (Exempting Monographs) Determination 2021

The TGA has amended Therapeutic Goods (Exempt Monographs) Determination 2021 to include the content of the sunsetting Therapeutic Goods (Exempting monographs of pharmacopoeias) Determination No. 1 of 2011, with minor amendments.

Therapeutic Goods (Exempt Monographs) Amendment Determination 2022 (‘the Amendment Determination’), amends the Therapeutic Goods (Exempt Monographs) Determination 2021 to continue to set out specific monographs of the USP that are not accepted as default standards as they are exempt from the definition of ‘standard’ in the Therapeutic Goods Act 1989.

iii) Standard no longer in force: Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines

Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines(link is external) (TGO 89) will sunset on 1 April 2022. This means it will no longer be in force and goods previously subject to TGO 89 can now be supplied in Australia.

TGO 89 specified that water for injections (WFI) must comply with the BP or the Ph. Eur. WFI monographs, and therefore could not be manufactured according to the USP WFI monograph.

Source: TGA Australia

USA
24 May
Electronic Certificates of Pharmaceutical Product: General Information

The FDA has updated the information in eCPPs, but no specifics have been provided on the update.

Source: FDA

17 May
FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program

Part of the FDAs mission is to protect and promote public health by helping to ensure that safe, effective, quality drugs are available to patients. The 2019 report Drug Shortages: Root Causes and Potential Solutions found that a root cause of past drug shortages is that the market does not recognize and reward drug manufacturers that have invested in achieving quality management maturity (QMM).

QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes in place to achieve quality objectives and promote continual improvement. Such business processes reduce the likelihood of supply disruptions and shortages.

To incentivise drug manufacturers to invest in QMM, the FDA has released a white paper which describes key considerations for measuring and rating a drug manufacturer’s QMM and their ability to deliver high-quality drugs reliably and without disruption. A QMM rating system could inform regulators and drug purchasers (e.g., distributors that ship drugs from manufacturers to pharmacies) about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of drugs.

The recently published white paper explains the need for a QMM program. It also covers key elements of such a program, which include an objective, standardized and validated assessment tool; a transparent, universally understood rating system; and clear incentives for industry to achieve higher ratings.

FDA is eager to engage with stakeholders on the development of a quality management maturity program and will be hosting a two-day workshop on May 24 and 25 for stakeholders to discuss their thoughts, perspectives and feedback.

Source: FDA

10 May
CDER Launches New Accelerating Rare disease Cures (ARC) Program

FDA’s Center for Drug Evaluation and Research (CDER) has launched a new Accelerating Rare disease Cures (ARC) Program. The vision of the ARC Program is to speed up and increase the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases.

FDA defines rare disease as any disease that affects less than 200,000 people in the U.S. Drug development for the approximately 7,000 rare diseases and conditions can be complex for many reasons:

  • There can be challenges with using well-established trial designs.
  • Endpoint selection can be complex if there is a limited understanding of the natural history of the disease.
  • Small patient populations can make it difficult to perform and interpret rare disease clinical trials.

In its first year, CDER’s ARC Program will focus on strengthening internal and external partnerships with stakeholders and will engage with external experts to help identify solutions for the challenges in rare disease drug development.

Source: FDA

31 March
Online Verification of eCPPs for Human Drug Products

Effective 25 March 2022, electronic Certificates of Pharmaceutical Product (eCPPs) issued by the U.S. Food and Drug Administration Center for Drug Evaluation will include a unique Quick Response (QR) code. This change will allow for quicker and easier verification of the authenticity of eCPPs. Anyone, including foreign governments, that receives an eCPP for human drug products exported from the U.S. FDA may verify the authenticity of these certificates using one of the following options:

  • Scanning a QR code with a camera application on your mobile phone
  • Using the FECV Portal for verification

You can find out more about both of the above options here.

Source: FDA

30 March
Pharmaceutical Quality/Chemistry, Manufacturing & Controls (PQ/CMC)

As part of an effort intended to support future electronic acquisition and use of submitted information, FDA has undertaken a project to identify and prioritise pharmaceutical quality/chemistry, manufacturing and controls (PQ/CMC) information that would benefit from a structured submission approach.

  • This structured and standardised information is intended to be submitted in the Module 3 of the Common Technical Document as defined by the International Council for Harmonisation’s (ICH) M4 Common Technical Document (CTD).
  • It is not intended to be comprehensive in covering all eCTD product quality information, only those concepts that were considered amenable to structuring and would bring value to the quality review process.

The goal of this project is to establish electronic standards for submitting Pharmaceutical Quality (PQ) and Chemistry & Manufacturing Controls (CMC) data.

Specific objectives of the PQ/CMC Project are:

  1. Develop structured data standards for PQ/CMC
  2. Develop a data exchange standard for submitting the structured PQ/CMC data to the FDA

The submission of structured data in a standardised format should increase the efficiency of FDA’s review of PQ/CMC data contained in the Module 3 of eCTD submissions for:

  • a New Drug Application (NDA),
  • an Investigational New Drug Application (IND),
  • a Biologics License Application (BLA),
  • an Abbreviated New Drug Application (ANDA),
  • a Master File (MF).

You can read more about this project here.

Source: FDA

Canada
19 May
Updated validation rules for regulatory transactions provided to Health Canada in the non-eCTD format

Last week, Health Canada updated its validation rules for regulatory transactions submitted in the non-eCTD format. These rules are built in accordance with the information provided in the following documents:

The purpose of the validation rules is to help ensure Sponsors provide a valid electronic transaction to Health Canada, and reduce errors and follow-up with Sponsors. Sponsors are encouraged to use a commercially available tool to validate their regulatory transactions in non-eCTD format, prior to filing them to Health Canada.

Health Canada validates each regulatory transaction as it is received. If the validation fails due to one or more errors detected, a Validation Report describing each error will be emailed to the sponsor as a .pdf file attachment.

Version of the non-eCTD validation rules: 5.1
Effective date: August 1, 2022

Source: Health Canada

22 April
Notice – Interim implementation of electronic labelling for human prescription drugs

Health Canada consulted on the draft guidance “Electronic media in prescription drug labelling” between March and May 2021.

Based on some stakeholder feedback received and additional considerations related to business delivery, this notice serves to communicate Health Canada’s intent to adopt the interim implementation measures detailed below.

  • As a general policy approach, replacement of physical labels (package inserts and other physical materials (generated by a sponsor that are included in the drug package or supplied at the time of dispensing), which satisfy regulatory requirements) with ‘electronic labels’ is not being considered at this time for human prescription drugs.
  • If Sponsors choose to include ‘links’ on their physical labels directing end-users to electronic platforms, the information contained on such electronic platforms should be limited only to the most up-to-date approved Product Monographs and/or Risk Management Plans or other Health Canada approved documents such as risk communications (i.e., verbatim copies).
  • This interim implementation approach may be revisited in the future, after further consultation with stakeholders.

At this time, there are no restrictions on what kind of ‘links’ may be used but consideration should be given to ensure adequate accessibility and legibility of the physical labels.

Further information is available at the link below.

Source: Health Canada

21 April
Draft revised Guidance document: Switching a medicinal ingredient from prescription to non-prescription status

Health Canada has updated the current guidance document in order to:

  • reflect a new process for prescription to natural health product switches
  • provide more guidance to support companies in developing high quality switch submissions

You can comment on the guide at the latest by 20 June 2022. The draft updated guidance and instructions on how you can comment on it are provided at the link below.

Brazil
1 June
DIFA Adequacy Letter: new features in the query tool

Anvisa can now carry out consultations on requests for expression of interest filed by holders of an Active Pharmaceutical Input Dossier (DIFA) who wish to obtain an Active Pharmaceutical Input Dossier Adequacy Letter (CADIFA ). In the consultation, it is possible to verify the DIFA holders who do not yet have CADIFA , but whose dossier is in accordance with the Resolution of the Collegiate Board of Directors (RDC) 359/2020 , which establishes the minimum requirements for Active Pharmaceutical Ingredients ( IFAs ) used in the manufacture of new, innovative, generic and similar medicines.  

  • The submission of CADIFA in registration and post-registration of new, innovative, generic and similar drugs is now optional, but as of August 1, 2023 , it will be mandatory for all submissions. 
  • An expression of interest is the instrument that demonstrates the interest of the DIFA holder in obtaining CADIFA withoout an associated  registration or post-registration petition of the drug.
  • Due to limited resources, Anvisa’s main priority is to analyse a CADIFA request associated with drug registration and post-registration petitions (as opposed to a request without a drug registration or post-registration petition) and that there is no deadline for analysing an expression of interest. 

To consult the Anvisa database, access https://consultas.anvisa.gov.br/#/listas/ and select “Pharmaceutical Input” in the “Area of ​​Interest” field, “CADIFA” in “List”, “Expression of Interest” | Expression of Interest ” under “ Sublist ” and click “Search” as indicated below:  

Source: Anvisa

18 May
Drug name complement has new subject code

Anvisa has made available a new subject code for drug name complement. Name complements must be used to distinguish a particular drug from another already registered by the same company, within a drug family. 

The new code (12142 – Inclusion of the name complement) must be used in Anvisa’s Electronic Petition System. 

The creation of the new code was necessary to remedy the absence of an administrative flow for the situation provided for in the Resolution of the Collegiate Board of Directors (RDC) 59/2014 . According to the RDC, a family of medicines is a set of pharmaceutical products from the same company, with the same drug(s) identifier(s), grouped by a common name and differentiated by individual complements.  

When to use the new code 

According to RDC 59/2014, name complements can be used to distinguish routes of administration, pharmaceutical form, target population, absorption or other situations, upon reasoned justification of the company.  

In other situations, the inclusion of the name complement is mandatory. This is the case of drugs that present different release speed, pharmaceutical form or route of administration within the same drug family. 

Source: Anvisa

4 May

Anvisa publishes RDC on nitrosamines and updated version of the guide

Anvisa has published Version 2 of the guide 50/2021 and the Resolution of the Collegiate Board of Directors (RDC) 677/2022 on the control of nitrosamines in active pharmaceutical ingredients (APIs) and medicines. Version 2 is already in effect and the rule will take effect on June 1st. The document gathers recommendations on corporate responsibility and presents strategies for calculating limits, among other requirements.  

RDC 677/2022 provides for compliance with the requirements in a staggered manner, in stages, according to the risk attributed to each product. Both the regulation and the guide are applicable to new drug registrations, as well as post-registration changes that may result in the formation of nitrosamines , such as changes related to API, composition and packaging of the drug, not being restricted exclusively to these. 

Source: Anvisa

24 March
Q & A document about the 24/2019 Guide on submissions in CTD format published

The first version of the Questions and Answers about the 24/2019 Guide (in Portuguese)  is available for consultation. Its objective is to detail the requirements for submission of registration and post-registration dossiers of new, innovative, biological, generic medicinal products in the CTD (Common Technical Document) format based on questions from the regulated sector. 

The publication of an updated version of the 24/2019 Guide is on the horizon.

The deadline for implementation for the eCTD (in line with the ICH Guide M8 Electronic Common Technical Document ( eCTD ) v4.0) agreed with the ICH is December 2023.

Source: ANVISA

Source: Anvisa website

 

Australia
27 June
Clinical evidence guidelines: Medical devices

TGA has published version 3.1 (June 2022) of the clinical evidence guidelines for medical devices.

  • These guidelines provide details and guidance on the clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs), under Australian legislation.
  • For IVDs, there is also a supplementary document titled ‘Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices’, which should be reviewed in conjunction with these guidelines.
  • The guidelines are intended to be a common reference point for both industry and the regulator – assisting sponsors and manufacturers to collect, compile and present clinical evidence in a manner that meets regulatory requirements, while reflecting the TGA’s approach to how it assesses clinical evidence.

Version 3.1 has the following updates:

  • Updated Part 1 – General Requirements – The Essential Principles
  • New chapter – Personalised medical devices (PMDs)
  • Updated – Total and partial joint prostheses
  • New chapter – Software as Medical Device
  • Updated – Abbreviations

Source: TGA

3 May
Regulation of software based medical devices

The TGA has aadded the fact sheet entitled Digital mental health: Software based medical devices to the information in this section.

Source: TGA

2 March
Medical devices reforms: Consumer / patient information materials requirements

The requirements are as follows:

DateInformation
Since 1 December 2021Manufacturers of all implantable devices in the ARTG (other than those excluded) are required to make patient information materials available. Patient information materials must meet the Essential Principles to be considered compliant. Otherwise, sponsors must apply for consent to import, supply, or export a medical device that does not comply with the Essential Principles.
Since 1 December 2018Manufacturers of all new permanently implantable or active implantable medical devices (other than those excluded) have been required to make patient information leaflets available to patients with the device.
On 26 October 2017,The Government approved regulations requiring patient information materials (patient information leaflets and patient implant cards) to be supplied with implantable and active implantable medical devices in Australia. These regulations have since been amended to allow a more flexible approach to how this information can be provided, including electronic formats.

Further information regarding the graduated transition timeframes is available at Patient implant cards and information leaflets.

Source: TGA

Ireland
22 June
CAMD certificates of free sale Q&A document

The Competent Authorities for Medical Devices CAMD has published a Q&A document entitled Questions and Answers on Certificates of Free Sale and Article 60 of Regulation (EU) 2017/745 on medical devices (MDR).

  • The aim of this document is to provide guidance in the area of certificates of free sale.
  • It considers how certificates of free sale should be processed or generated for ‘legacy’ and MDR-compliant devices.
  • It highlights where certificates of free sale can be issued in the context of Article 60 (1) of the Regulation and where the use of national provisions may be required.

Source: HPRA

21 June
Notification of a Performance Study for a Companion Diagnostic using left-over samples under Article 58(2) IVDR

Performance studies involving companion diagnostics using only left-over samples require notification to the HPRA under Article 58(2) of the IVDR.  

Sponsors of these performance studies should note the general requirements for performance studies as specified in Article 57 and the requirements for recording and reporting of adverse events under Article 76 of the IVDR. Please refer to the HPRA Guide to Performance Studies Conducted in Ireland for further details.

Notification of a Performance Study of a CE Marked IVD (Article 70 IVDR)

This notification form only applies to performance studies where the proposed use is consistent with the intended purpose of the device. Where a CE marked device is proposed to be used outside the scope of its intended purpose, an application to undertake a performance study of the IVDR should be made instead. Please refer to the HPRA Guide to Performance Studies Conducted in Ireland for further details.

Source: HPRA

17 June
Guide to Performance Studies for IVDs Conducted in Ireland

HPRA has published the above guide.

The guide:

  • provides an overview of legislation and key concepts relevant to performance studies (PS) involving in vitro diagnostic medical devices (IVDs). In addition, information is provided on how to submit applications or notifications to HPRA.
  • is targeted at PS sponsors (e.g. manufacturers, academic groups, clinical research organisations) who wish to conduct PS involving IVDs in Ireland. The information may also prove useful for ethics committees and other stakeholders.
  • does not purport to be the definite interpretation of the law and/or regulations and is for guidance purposes only. Relevant legislation relating to in vitro diagnostic medical devices should be consulted in addition to this guide (see Appendix 1 for examples)

Source: HPRA

9 June
New form for notification of substantial modification of a clinical investigation of a medical device

The above new form is available for download here.

As described in Article 75 of EU Regulation 2017/745 (MDR), if the sponsor wishes to introduce modifications to a clinical investigation in Ireland that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, they are required to notify the HPRA of these modifications at least 38 days prior to implementation.

This requirement applies to all clinical investigations that fall under Article 62 or Article 74 of the MDR. In Ireland, this also applies to clinical investigations that fall under Article 82 of the MDR and national legislation (Part 3 of the Medical Devices Regulations 2021, S.I. 261 of 2021), if stated as an additional requirement in the HPRA’s letter of acknowledgement of notification of an Article 82 study. 

Source: HPRA

26 May
Medical Devices Newsletter Issue 55

The HPRA has published Issue 55 of its Medical Devices Newsletter. As always, it is packed with veryuseful information. Much of the information can be useful to the wider EU audience.

The topics included in this edition of the newsletter are:

  • IVDR Transition Timelines
  • IVD Registration Requirements
  • Supply Chain Activities – Your Role
  • MDCG Recent Publications
  • HPRA Stakeholder Resources:
    • Decision tree for IVDR
    • performance studies
    • IVDR webinar, including Q&A -Responses are providedc to more than 30 questions asked during the IVDR webinar.

Source: HPRA

Request for performance study pre-submission meeting – form

It is recognised that interaction may be sought with the HPRA at different stages of development of an in vitro diagnostic medical device (IVD). Some of the information requested on this form may not be available to all organisations seeking advice, but please provide as much detail as possible. If there is not enough space in the boxes provided, please attach any relevant documentation to this form.

Source: HPRA

Brazil
1 June
New regulation on CBPF of medical devices comes into force

Today, the  Resolution of the Collegiate Board of Directors (RDC) 687/2022 comes into force. It provides the criteria for granting or renewing the Certification of Good Manufacturing Practices (CBPF) of devices doctors. The standard replaces  RDC 183/2017 .  

The measure defines the possible forms of certification of medical device manufacturers adopted by the Agency, as well as simplifies the list of documents to be presented for renewal of current certifications.   

In addition, the new resolution aims to bring clarity to the doubts frequently raised by the old standard, for example, with regard to manufacturing plants subject to certification.    

Another innovation is the disclosure of the risk matrix used by Anvisa in the certification process, which aims to provide more transparency to the process and predictability to the productive sector.  The risk matrix is ​​an important tool and the result of its application, together with the evaluation of the information contained in the petitions, will support Anvisa’s decisions regarding certification requests.    

Source: Anvisa

Switzerland
26 May
New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022

On 4 May 2022, the Federal Council adopted the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and the amendment to the Ordinance on Clinical Trials with Medical Devices (CTO-MedD).

  • The aim of the new regulations is to improve patient safety by means of stricter requirements for conformity assessment and post-market surveillance.
  • The new legal requirements enter into force on 26 May 2022, at the same time as the application of the IVDR in the EU.
  • From 26 May 2022, clinical trials with in vitro diagnostic medical devices will be regulated in the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) and no longer in the Ordinance on Clinical Trials (ClinO).               

Source: Swissmedic

25 May
New rules for performance studies with IVDs from 26 May 2022

For all performance studies, with the exception of the performance studies listed in Art. 2a para. 1-3 Ordinance on Clinical Trials with Medical Devices (ClinO-MD), the provisions of ClinO-MD apply as of 26 May 2022.

Please refer to the Swissmedic information sheet on interventional performance studies: BW600_00_016e_MB, available here.

  • The above mentioned Information sheet contains a decision tree to help you determine whether your research project must be submitted to Swissmedic.
  • Performance studies that have to be submitted to Swissmedic according to the decision tree also need to be authorised by Swissmedic and the responsible cantonal ethics committee.
  • Applications for the authorisation of category C performance studies and any subsequent submissions in the authorisation procedure must be sent on the same day to Swissmedic and the responsible cantonal ethics committee.
  • Swissmedic can issue an authorisation only if the ethics committee has already approved the same version of the trial documentation.

Further clarification is available on the website of the Coordination Office for Human Research (kofam), here.

Source: Swissmedic

3 March
Unique identification number (CHRN – Swiss Single Registration Number)

Swissmedic, assigns the Swiss Single Registration Number (CHRN) based upon the Medical Devices Ordinance (MedDO; SR 812.213).

The CHRN is:

  • a unique identification number that Swissmedic assigns to Swiss manufacturers, authorised representatives and importers upon request.
  • iused to unambiguously identify a manufacturer, authorised representative or importer.

Until the MRA (Mutual Recognition Agreement) is updated, Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland. To mitigate the consequences of this loss of information and to continue to ensure market surveillance in Switzerland, it is necessary for manufacturers, authorised representatives and importers domiciled in Switzerland to register once with Swissmedic.

  • Economic operators must register within three months of placing their first product on the Swiss market. 
  • This timeframe is intended to avoid delays in bringing compliant products onto the market and to prevent supply bottlenecks in Switzerland.
  • Once an economic operator has registered, it does not have to do so again when placing further products on the market.

On this page, you will find an information sheet which describes the process for applying for a CHRN in detail.

Source: Swissmedic

2 March
Medical Devices database

In the absence of an operational agreement between the Swiss Confederation and the European Union on the mutual recognition of conformity assessments (MRA), registration of economic operators (CHRN) and unique device identifier (UDI) is carried out directly by Swissmedic.

Swissmedic is currently designing a new database for registering economic operators and medical devices. Due to the continuing aim of equivalence between regulation in Switzerland and the EU, the medical devices database will be similar to EUDAMED. The new medical devices database will include registration of economic operators and medical devices. It will be possible to register medical devices by mass upload.

Economic operators who are already registered with Swissmedic or who register before the introduction of the medical devices database (unique identification number, CHRN) will not be required to register again (data migration).

Swissmedic will communicate a schedule for the introduction of the medical devices database by the middle of this year.

The MedDO articles on device registration will come into force at a later date (see Art. 110 para. 2 MedDO), as the database required must be available first.

Source: Swissmedic

European Commission
11 May

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council was amended on 4 January 2022. It has since been amended on 11 May. The changes concern the Annex of the implementing decision. Entry 10 in the Annex has been replaced and entries 15 and 16 added.

Surce: Europa Website

11 April
Updated Technical information

The following updated modules are now available at the links below:

Source: European Commission

28 January
European Commission publishes amending regulation on transitional periods for IVD Regulation (EU) 2017/746

On 28 January 2022, the European Commission published in the Official Journal of the European Union an amending regulation (Regulation (EU) 2022/112) on the transitional provisions for the application of the IVD Regulation and on the suspension of the conditions for devices manufactured by a healthcare unit for its own use. The regulation entered into force on the day of its publication. The IVD Regulation will replace the old national regulation based on the IVD Directive and is due to become fully applicable on 26 May 2022.

The amending regulation applies a step-by-step risk-based model, which requires a notified body to carry out a conformity assessment by different dates. New transition schedules defined in the amending regulation are:

  • for higher risk devices such as HIV or hepatitis tests (category D) and certain influenza tests (category C), the transition period extends to  May 2025 and May 2026;
  • for lower risk devices such as Class B and sterile Class A devices, the transition period extends to  May 2027.

The amending regulation does not provide for a transitional period for the lowest risk category (A non-sterile) devices.

The changes to the regulation’s transition periods only apply to devices that are already on the market in May 2022 under the old regulations. The change in the transitional periods of the Regulation does not allow completely new devices to be placed on the market with less stringent requirements under the old regulation after the date of application of the Regulation on 2 May 2022.

For example, the regulations on post-market monitoring and incident reporting, as well as on distributors and importers, will also enter into force for transitional equipment according to the original timetable. 

International Medical Device Regulators Forum (IMDRF)

A draft document entitled Principles and Practices for the Cybersecurity of Legacy Medical Devices. has been published by the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Guide (MDCG) Working Group for public consultation.

The document is designed to provide concrete recommendations on how to apply the Total Product Life Cycle (TPLC) to legacy devices to aid in the implementation of the framework put forward in the preceding IMDRF N60 guidance. This document is complementary to the IMDRF N60 guidance, and the scope of relevant medical devices, as well as the focus on potential for patient harm remain unchanged.

It considers cybersecurity in the context of medical devices that either contain software, including firmware and programmable logic controllers (e.g., pacemakers, infusion pumps) or exist as software only (e.g., Software as a Medical device (SaMD)). It is important to note that due to most regulators’ authority over medical device safety and performance, the scope of this guidance is limited to consideration of the potential for patient harm. For example, threats that could impact performance, negatively affect clinical operations or result in diagnostic or therapeutic errors are considered in scope of this document. While other types of harm such as those associated with breaches of data privacy are important, they are not considered within the scope of this document

The consultation is open until Sunday 3 July 2022.

Source: IMDRF

Taiwan
31 March
New online Medical Device Electronic Pre-market Application Platform:TFDA Medical Device Premarket E-Submission System

The Medical Devices Act took effect on May 1, 2021. TFDA accelerated the development of the E-submission System, and officially launched it on January 21, 2022 together with the following documentation:

  • Implementation Instructions for the Application for E-Submission of Class II and III Medical Device Registration,
  • The system user manual
  • Common Q&A

Medical device manufacturers or dealers can choose to apply for Class II and III Medical Device registration, alteration of the registration or license extension via this platform.

The platform aims to provide manufacturers with an alternative way to submit pre-market application documents in order to improve the convenience of pre-market applications for medical devices and to comply with the trend of paperless applications which can save the resources required to prepare paper documents. TFDA encourages but does not compel manufacturers to submit pre-market applications for class II and III medical devices via this new platform.

According to the Medical Devices Act, for the manufacture and import of medical devices:

  • an application shall be filed with the central competent authority (TFDA) for registration and market approval.
  • no manufacture or import shall be allowed until such approval is granted and a medical device license is issued.

Souirce: TFDA

ICH
31 March

The proposed guidelines Q2(R2) and Q14 are intended to complement ICH Q8 to Q12 Guidelines, as well as on-going ICH Q13 for Continuous Manufacturing, with a view to potentially combine both documents into one, for simplification and clarity.

The ICH Q14 draft Guideline on Analytical Procedure Development reaches Step 2 of the ICH process

The ICH Q14 draft Guideline on Analytical Procedure Development reached Step 2 of the ICH process on 24 March 2022 and now enters the public consultation period.

The new guideline is proposed to harmonise the scientific approaches of Analytical Procedure Development, and to provide the principles relating to the description of Analytical Procedure Development process. This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

Further information can be found on the ICH Q14 webpage.

The ICH Revision of Q2(R2) draft Guideline on Validation of Analytical Procedures reaches Step 2 of the ICH process

The ICH Revision of Q2(R2) draft Guideline on Validation of Analytical Procedures reached Step 2 of the ICH process on 24 March 2022 and now enters the public consultation period.

The scope of the revision of ICH Q2(R1) will include validation principles that cover analytical use of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR or MS) some of which often require multivariate statistical analyses. The guideline will continue to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B. The proposed guidelines Q2(R2) and Q14 are intended to complement ICH Q8 to Q12 Guidelines, as well as on-going ICH Q13 for Continuous Manufacturing, with a view to potentially combine both documents into one, for simplification and clarity.

Further information can be found on the ICH Q2(R2) webpage.

1 February
PIC/S GMP guide revised to reflect EU Clinical Trials Regulation

The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include:

  • a revised Annex 13 on the Manufacture of Investigational Medicinal Products; and
  • a new Annex 16 on the Certification by the Authorised Person and Batch Release

PIC/S Annex 13 has been revised based on the Regulation (EU) No 536/2014 (Clinical Trials Regulation) which will replace EU Annex 13. This is in line with the Co-operation Agreement between PIC/S and EMA, which provides that the PIC/S and EU GMP Guides should be harmonised with the aim of keeping GMP standards equivalent, thus facilitating the exchange and use of information concerning the manufacture of medicinal products.

PIC/S Annex 16 is a new annex to the PIC/S GMP Guide. Historically, PIC/S did not adapt EU Annex 16, when it was adopted as part of the EU GMP Guide. Initially, PIC/S considered this annex to be EU-specific and difficult to transpose for PIC/S purposes, in particular since the PIC/S GMP Guide is limited to the manufacture of medicinal products and not to import and distribution. Following a consultation of PIC/S Participating Authorities in 2017, it was agreed to make an attempt to transpose EU Annex 16, considering that a PIC/S adaptation could offer added benefit to better convey expectations associated with product release and further international harmonisation efforts in line with PIC/S’ mission to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products. PIC/S also agreed that elements in Annex 16 related to imported medicinal products would be voluntary, dependent on national law.

The revised GMP Guide (PE 009-16), with the revised Annex 13 and the new Annex 16, entered into force on 1 February 2022. This coincides with the entry into force of Regulation (EU) No. 536/2014 on Clinical Trials replacing EU Annex 13. 

Source: PIC/S

16 May
AI dermatology company Skin Analytics has been granted a UKCA mark by the UK MHRA.

AI dermatology company Skin Analytics has been granted a Class IIa UKCA mark by the UK MHRA.

Using AI, the company’s medical device, DERM is designed to accelerate patient diagnosis by ensuring urgent cases are identified early and moved into care quicker. The organisation works with NHS Partners to design new patient pathways that leverage DERM to assess more patients faster. This has the scope to reduce wait times for urgent cases and ease pressure on the NHS, which currently faces a shortage of dermatologists.

James Hamlyn, quality assurance and regulatory director of Skin Analytics said: “Skin cancer rates are doubling in the UK every 10-15 years and about 30% of dermatology posts in the NHS are unfilled. Healthcare systems are not equipped to deal with the volume of patients they need to see, especially in the light of the backlog created by COVID. AI can bridge this gap.

DERM uses machine learning to support clinicians in recognising the most common malignant, pre-malignant and benign skin lesions including melanoma, the most dangerous of the common skin cancers and the fifth most common cancer in the UK.

The AI technology is currently supporting clinicians with a decision support service in five NHS sites across the country and with their partners, have assessed more than 23,000 NHS patients, found 1,473 skin cancers, and avoided 4,713 dermatology appointments.

The UKCA mark validates Skin Analytics’ 10-year history of re R&D on skin lesions. DERM is being used across the NHS and the classification is expected to unlock alternative pathways to diagnosis. As AI continues to play a larger role in skin cancer diagnosis, the organisation will be expected to meet further quality standards and is also working with regulatory agencies such as the US FDA to help shape standards for AI supported care.

The certification is the first step in enabling the company to unlock new pathways with NHS Trusts, aiming to further support the NHS with outpatient demand in dermatology.

Source: Med-Tech Innovation News

15 May
Study finds that robot-assisted surgery for patients undergoing major abdominal operations can cut blood clot risk and speed recovery

Doctors and scientists have said that patients having major abdominal operations should be offered the option of robotic surgery, after a world-first clinical trial found the procedures dramatically speed up recovery times, reduce complications and cut the risk of blood clots.

In a first-of-its-kind three-year study, experts at University College London (UCL) and the University of Sheffield discovered that patients having robot-assisted bladder cancer surgery recovered faster and returned home sooner than patients who had open surgery. The findings were presented at the American Urological Association annual meeting in New Orleans, Louisiana.

Robotic surgery reduced the chance of re-admission by half (52%), and led to a 77% reduction in the prevalence of blood clots, when compared with patients who had open surgery. Researchers said the findings challenged the notion that open surgery was the “gold standard” for major operations.

The trial ran from March 2017 to March 2020 and involved 29 surgeons at nine UK hospital trusts. A total of 338 patients with non-metastatic bladder cancer were split into two groups, with 169 patients having robot-assisted bladder removal and reconstruction, and 169 patients having open surgery.

According to Prof James Catto, a professor of urological surgery at the University of Sheffield, “Previous trials of robotic surgery have focused on longer term outcomes,. They have shown similar cancer cure rates and similar levels of long-term recovery after surgery. None have looked at differences in the immediate days and weeks after surgery.”

Researchers found that, on average, the robot-assisted group stayed eight days in hospital, compared with 10 days for the open surgery group. Re-admittance to hospital within 90 days of surgery was also reduced, they said, at 21% for the robot-assisted group and 32% for those who had open surgery.

A further 20 secondary outcomes were assessed at 90 days, six- and 12-months post-surgery. These included blood clot prevalence, wound complications, quality of life, disability, stamina, activity levels, and survival (morbidity). All secondary outcomes were improved by robot-assisted surgery or, if not improved, almost equal to open surgery. 

It is important to notethe last key point of this study published on the JAMA network website which states the following:

Meaning  Robot-assisted surgery compared with open surgery for radical cystectomy among patients with bladder cancer resulted in a statistically significantly higher number of days alive and out of the hospital, but the clinical importance of this difference is uncertain.

Sources:

The Guardian

JAMA Network

16 April
UK NHS developed smartwatch for Parkinson’s patients hailed as ‘lifechanging’

Thousands of people with Parkinson’s disease will be given smartwatches by NHS England so they can be treated effectively from home.

The Parkinson’s KinetiGraph (PKGTM) consists of a small device worn on the wrist for collecting data over a period of 6-10 days and provides a report for the doctor that shows how motor symptoms and complications of Parkinson’s disease (PD) such as slowness of movement, stiffness, tremor and dyskinesias vary throughout the day.

Information collected by the PKGTM will guide the doctor to see how people with PD are functioning at home and to identify any troublesome problems or symptoms. This important information enables the doctor to see how current medication affects motor symptoms and complications.

It also allows doctors to decide in conjunction with the person with PD on whether the amount of medicine needs to be decreased, increased, or changed to another medicine that is more effective in controlling their symptoms.

The PKGTM :

  • also reminds people with PD when it’s time to take their prescribed medication whilst helping the patient acknowledging the time the medication was taken. This helps achieve and demonstrate compliance in taking medication and provides important information on how movement symptoms are impacted by taking the medication.
  • is able to capture information about daytime sleepiness and night-time disturbances. This enables the doctor to see when an individual has been asleep during the day. Furthermore, the sleep data provides important information that is a major aid for better management of these problems.

The NHS England chief executive, Amanda Pritchard, said the watch would help improve the quality of life for 120,000 Parkinson’s patients while improving efficiency in the NHS.

The watch was developed by the NHS in Plymouth and the University of Plymouth. Dr Camille Carroll, the neurology expert who led the pilot, described the invention as “lifechanging”.

The watch is not expected to entirely replace face-to-face time between Parkinson’s patients and their doctors. Patients will still be required to fill out questionnaires for their doctors to aid their understanding of possible causes of night-time disturbances that cannot be recorded by the device.

Sources:

The Guardian

Dementech Website

14 April
FDA Authorizes First COVID-19 Diagnostic Test, InspectIR COVID-19 Breathalyzer which uses breath samples which can provide results in less than three minutes

The U.S. FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test, InspectIR COVID-19 Breathalyzer that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

The test:

  • can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage
  • is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorised by state law to prescribe tests and can provide results in less than three minutes.

The performance of the test was validated in a large study of 2,409 individuals, including those with and without symptoms. In the study, the test was shown to have:

  • 91.2% sensitivity (the percent of positive samples the test correctly identified) and
  • 99.3% specificity (the percent of negative samples the test correctly identified). 

The test uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath. When the test detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test.

Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, as they do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

Source: FDA

5 April
An AI tool, ChestLink that reads chest X-rays without oversight from a radioglogist granted an EU CE Mark

An artificial intelligence tool, ChestLink that reads chest X-rays without oversight from a radiologist got regulatory clearance in the European Union last week. Oxipit was granted CE Class IIb certification for its ChestLink autonomous AI imaging suite. According to a statement from Oxipit, the company responsible for ChestLink, this is a first for a fully autonomous medical imaging. The tool, called ChestLink, scans chest X-rays and automatically sends patient reports on those that it sees as totally healthy, with no abnormalities. Autonomus AI reporting in medical imaging means that an AI application produces the final report of the imaging study without any involvement from a human doctor. The AI produces a final diagnosis on its own upon which future treatments decisions will be made. It’s a big milestone for AI and likely to be contentious, as radiologists have spent the last few years pushing back on efforts to fully automate parts of their job.

ChestLink, scans chest X-rays and automatically sends patient reports on those that it sees as totally healthy, with no abnormalities. Any images that the tool flags as having a potential problem are sent to a radiologist for review.

Oxipit said in a statement that ChestLink made zero “clinically relevant” errors during pilot programs at multiple locations. When it is introduced into a new setting, the company said there should first be an audit of existing imaging programs. Then, the tool should be used under supervision for a period of time before it starts working autonomously.

The company said in a statement that it expects the first healthcare organizations to be using the autonomous tool by 2023.

Oxipit spokesperson Mantas Miksys told The Verge that the company plans to file with the FDA as well.

Source: The Verge

9 March
Veros COVID-19, a CE marked test provides lab quality results in 15 minutes

The company Sense Biodetection has received CE marking for Veros COVID-19, a fully integrated, molecular diagnostic test that provides laboratory-quality results in 15 minutes. 

Unconstrained by an instrument or reader and using an anterior nasal swab, Veros COVID-19 was designed for use in near-patient environments, such as hospital emergency departments, pharmacies, care homes, and urgent care, providing accurate results and streamlining clinical decision making. The company anticipates launching Veros COVID-19 in Europe this quarter, initially in Ireland, Benelux, and the Nordic regions.

Analytical performance testing has demonstrated that Veros COVID-19 is over 1,000 times more sensitive than widely used antigen tests. It brings the performance of lab-based PCR tests, which detect approximately 30% more true positives than antigen tests, directly to the point of care. In addition, where the performance of some antigen tests has waned with new variants, Veros COVID-19 has maintained 100% conservation in all Variants of Interest and Concern identified to date by WHO and US CDC.

Veros COVID-19’s clinical performance was established via a multicentre study which prospectively enrolled nearly 300 evaluable subjects during both the Delta and Omicron variant surges of the pandemic. All study sites represented near-patient testing/point-of-care environments, with all test operators reporting no prior formal laboratory training or experience.

Veros COVID-19 results were compared directly against a highly sensitive, CE Marked and WHO & US FDA emergency authorised qRT-PCR test, from a developer and manufacturer of laboratory diagnostics. In 15 minutes, the Veros COVID-19 delivered:

  • 97.9% Accuracy (286/292), 
  • 95.2% Sensitivity (99/104); and
  • 99.5% Specificity (187/188).
  • 100% of operators agreed the Veros COVID-19 was easy-to-use, read and understand the results, with minimal hands-on time required from start to finish.

Source: Med-Tech News

4 March
Progress on Injectsense’s Implantable Autonomous IOP Sensor for glaucoma

Injectsense Inc., a sensor-enabled digital health company has been awarded a two-year, $1.7M Small Business Innovation Research (SBIR) grant from the National Eye Institute of the National Institutes of Health, for the IOP-Connect™ system. The latter is based on an implantable intra-ocular pressure (IOP) sensor platform smaller than a grain of rice, that for the first time is expected to provide continuous and autonomous long-term IOP data from inside a glaucoma patient’s eye. 

The funding follows IOP-Connect’s FDA Breakthrough Device Program (BDP) designation in 2020 and covers two activities:

  • the integration of advanced technologies for the final product configuration — including a rechargeable, thin-film microbattery; and
  • a second round of bench testing and animal testing this year that will be managed by the Johns Hopkins Wilmer Eye Institute.

The results will inform GLP studies in animals and pilot human studies, scheduled for this year, as the company prepares for a CE Mark and an FDA Investigational Device Exemption (IDE) submission. 

Source: Injectsense

17 February
Novacyt announces approval of its PROmate® COVID-19 2G Real-Time PCR test

Novacyt has announced that the Company’s PROmate® COVID-19 2G Real-Time PCR test has been approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (“CTDA”).

  • The PROmate® COVID-19 2G test is the first direct-to-PCR product to be added to the CTDA register of approved products and is designed to detect two SARS-CoV-2 targets within ORF1ab in response to an increasing shift from single-gene to multi-gene testing solutions.
  • Direct-to-PCR products remove the need for complex, manual or automated extraction solutions and are designed to significantly improve laboratory workflow and reduce costs. It also allows testing to take place away from traditional, laboratory-based settings due to simplicity and ease of use.
  • Therefore, the PROmate® COVID-19 2G PCR test is well suited for industries such as travel, sport, film, media, and workplace settings.

Source: Novacyt website

9 February
Aptar Pharma launches HeroTracker Sense, a digital respiratory health solution that turns a standard metered dose inhaler (pMDI) into a smart connected healthcare device

Aptar Pharma has launched HeroTracker®Sense, a digital respiratory health solution that turns a standard metered dose inhaler (pMDI) into a smart connected healthcare device.

HeroTracker Sense is a metered-dose inhaler (MDI) add-on connected device, designed to address patient inhalation technique and adherence.

The canister of an MDI is attached to HeroTracker®Sense which has several features that help asthma and COPD patients take their medication in a more informed way. The sensors in the device enable the creation and supply of information such as co-ordination of inspiration with actuation, flow rate and inhalation duration. Other features available through the app include date and time stamps to indicate when the patient should take their medication, as well as environmental monitoring alerts such as temperature and humidity.

HeroTracker®Sense offers healthcare providers valuable analytics and insights into patient training, onboarding and performance through the Aptar Pharma Cohero Health BreatheSmart Connect Portal, which is both HIPAA and GDPR compliant, while patients can monitor their adherence through the BreatheSmart app.

HeroTracker®Sense is CE marked and is pending FDA approval.

Source: Med-Tech Innovation News

27 January
Digital health platform PocDoc to launch world-first smartphone-based test for cardiovascular disease

PocDoc the digital health platform is on track to launch its world-first smartphone-based test for cardiovascular disease. It will initially be available to healthcare distributors and businesses such as private healthcare providers, pharmacies, care workers and NHS providers, with a wider public roll out planned for later in 2022 that will enable people to test themselves at home.

Currently finishing its NHS research trials with an aim to launching this Spring, this new, world-first personal diagnostic technology for cardiovascular disease will aid early detection, allowing anyone with a smartphone or tablet to take an accurate blood test from wherever they are, with results available via the PocDoc app.

The PocDoc test will cover the full five marker lipid panel that has been established as the gold standard for cardiovascular assessment. In six minutes, someone will get the same markers tested using a smartphone anytime, anywhere, instead of waiting days or weeks for the same result through a standard lab test.

According to The World Health Organisation, cardiovascular diseases (CVDs) are the leading cause of death globally, claiming an estimated 17.9 million lives each year.

Source: Med-Tech news

26 January
Phillips-Medisize and startup SOTECH Health collaborating to develop an AI based breath-sensor system that detects COVID-19 in less than 30 seconds

Phillips-Medisize, a specialist company in drug delivery, diagnostic and medtech devices, is collaborating with Dallas-based healthcare start-up SOTECH Health to accelerate the development of a breath-sensor system that detects COVID-19 in less than 30 seconds. 

SOTECH Health’s reusable breath-test device leverages sensor research from The University of Texas at Dallas with a cloud-based artificial intelligence (AI) platform and Phillips-Medisize’s human-centred product design, rapid prototyping, and end-to-end manufacturing expertise. 

At the heart of each device is electrochemical sensor technology developed by Dr. Shalini Prasad, a professor of bioengineering at UT Dallas. Additional location, temperature, humidity, and communication sensors gather relevant data, along with test results, which are sent to a cloud-based artificial intelligence (AI) model. A suite of machine learning and predictive analytics tools based on sensor and AI IP owned by SOTECH Health assess results, determine probability of future infection, and provide geographic “heat maps” created from aggregated data within a geographic region. 

  • To screen for COVID-19, a person blows into the handheld device’s disposable mouthpiece for six seconds.
  • A sensitive, electrochemical sensor looks for traces of certain chemicals in the sample, which indicate exposure to SARS-CoV-2, the virus strain that causes COVID-19. Results are available in less than 30 seconds. 
  • Tests can be self-administered and monitored on site or from a distance through WiFi/Bluetooth connectivity, alleviating the need for healthcare professionals to conduct the tests.
  • To date, SOTECH Health has completed 31,000 breath tests.

Craig Micklich, founder and CEO of SOTECH Health, said: “Our innovative breath analyser will change the game in COVID-19 detection by quickly and accurately screening people in densely populated settings, such as airports, businesses, cruise lines, schools and stadiums

SOTECH Health has submitted the device to the U.S. FDA for emergency use authorszation and is awaiting regulatory approvals from Health Canada, the UKs MHRA and form the European Union.

Source: Med-Tech news

20 January
Elon Musk’s brain chip startup preparing to launch clinical trials in humans

Elon Musk’s brain chip startup is preparing to launch clinical trials in humans.

Musk, who co-founded Neuralink in 2016, has claimed that the technology “will enable someone with paralysis to use a smartphone with their mind faster than someone using thumbs”

The company which has already successfully implanted artificial intelligence microchips in the brains of a macaque monkey named Pager and a pig named Gertrude, is now recruiting for a “clinical trial director” to run tests of the technology in humans.

Musk said, “We hope to have this in our first humans, which will be people that have severe spinal cord injuries like tetraplegics, quadriplegics, next year, pending FDA approval,” he told the Wall Street Journal’s CEO Council summit.

Source: The Guardian

9 January
InWith Corporation promises world’s first soft smart contact lens

There are several companies hoping to make the concept of contact lenses that can deliver real-time information to the human eye, a reality. 

One of those companies is InWith Corporation which has developed the world’s first soft electronic contact lens. In an interview with CNET, CEO Michael Hayes says the lenses will work with your smartphone or another external device to show you real-time information about the world around you. “You’ll be able to see things such as, What is the speed limit on this road? What direction am I heading? Where is the next exit and how many miles away?”

Hayes also says the lenses will have the ability to help people who suffer from Presbyopia (the loss of the ability of your eyes to focus on nearby objects) by adjusting to different scenarios in real-time, eliminating their need for multifocals or reading glasses.

Hayes says the company is aiming for Food and Drug Administration approval this year.

Source: cnet

South Africa
14 January

SAHPRA has signed a Memorandum of Understanding (MOU) with the U.S. Pharmacopeia (USP) to help expand the availability of health products, including medical devices, that are safe, efficacious, and of assured quality.

SAHPRA is collaborating with USP to support SAHPRA’s three pillars of safety, quality, and efficacy and its overall aim to achieve the World Health Organisation Maturity Level 4, designated for regulatory systems that operate at the most advanced levels of performance. These advances will help accelerate and expand access to essential health products and improve oversight of the growing local pharmaceutical and health products manufacturing industry in South Africa. To this end, SAHPRA and USP will collaborate to:

  • Strengthen capacity for the adoption of risk-based approaches for regulatory inspections and post-marketing surveillance
  • Strengthen quality control laboratories for medicines, biologicals, and vaccines as well as medical devices
  • Collaborate on advancing regional regulatory harmonisation initiatives of strategic importance for SAHPRA and USP
  • Contribute to improving public health in Africa by promoting timely access to quality-assured health products and advancing innovation.

Source: SAHPRA

Australia
20 June
Consultation on the adoption of international scientific guidelines in Australia

The TGA is seeking feedback on whether or not certain international scientific guidelines should be adopted. It has approximately 370 current adopted international scientific guidelines.

While international scientific guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements. Any deviation from a guideline relevant to an application to register or vary the registration of a medicine must be justified.

On this occasion, the TGA is seeking feedback on whether or not the following international scientific guidelines, as detailed in the online survey, should be adopted:

1) Guideline on registry-based studies (EMA/426390/2021

2) Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man. The use of patient-reported outcome (PRO) measures in oncology studies (EMA/CHMP/292464/2014) 

Consultation start date: 20 June 2022

Consultation end date: 29 July 2022

Source: TGA

Canada
14 June
Draft ICH documents for consultation

Health Canada has published links to the following draft documents for consultation:

Document Consultation
start date
Consultation
end date
Release of Draft (Step 2) ICH Guideline Q2(R2): Revision to Analytical Validation13 June 202213 Sept 2022
Release of Draft (Step 2) ICH Guideline Q14: Analytical Procedure Development13 June 202213 Sept 2022
Release of Draft (Step 2) ICH Guideline E11A: Paediatric Extrapolation13 June 202213 Sept 2022

Source: Health Canada


Recently finalised ICH guidelines
DocumentType of noticeAdditional notes
E14/S7B: Questions & Answers – Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic PotentialStep 4 – Final Q&A DocumentThis Q&A document was implemented on June 10, 2022

Source: Health Canada

Ireland
Stakeholder consultation – Registration of processes exempted under Article 61(5) and applicable requirements under Article 61(6) of the Clinical Trials Regulation

Article 61(5) of the Clinical Trial Regulation (CTR) (EU Regulation 536/2014) provides an
exemption from the requirement to hold a manufacturer’s authorisation for the following
processes, where they are carried out in a hospital, health centre or a clinic participating in the clinical trial;
a) Re-labelling or re-packaging of the investigational medicinal product (IMP)
b) Preparation of radiopharmaceuticals used as diagnostic IMPs
c) Preparation of an IMP in accordance with a doctor’s prescription or in accordance with a
pharmacopoeial monograph.

THe HPRA has published a consultation document relating to the registration of processes exempted under Article 61 (5) and applicable requirements under Article 61 (6) of the Clinical Trials Regulation. It is seeking feedback from stakeholders on the followingitems:

Start date of consultation: 30 May 2022

Closing date of consultation: 22 August 2022

Source: HPRA