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 now been added for each region (below). Click on the respective tab to view the news for that region.

The latest updated section(s) are:

  • Medical Devices (Ireland) – 30 November
  • Rest of Europe (UK) – 30 November
  • Medical Devices (USA) 29 November
  • Medical Devices (Australia) – 26 November
  • EU (Ireland) – 25 November
  • Other (ICH) – 25 November
  • EU (European Medicines Agency) – 24 November
  • North America (Canada) – 23 November
  • Medtech – 22 November
29 November
MHRA provides additional information on requesting a UK PSMF number

The UK MHRA has provided additional guidance on requesting a UK pharmacovigilance system master file (PSMF) number on its website,here.

16 November
Managing Clinical Trials during COVID-19: Urgent Safety Measures update

The MHRA has updated the section on Urgent Safety Measures. No other specific information is provided on the update.

Source: MHRA website

25 October
MHRA information update regarding changes to a trial’s protocol or documentation

The MHRA has updated information regarding changes to a trial’s protocol or documentation. The updated information is available here under the heading Apply to change your trial’s protocol or documentation.

Changes to a trial’s protocol or documentation count as a substantial amendment to your clinical trial authorisation. You need to send a revised application form and notification of amendment form, plus the the documents listed at the link above, to the MHRA.

  • cover letter
  • the SmPC currently approved by corresponding EU procedure
  • the packaging labels and leaflets as currently approved by the corresponding EU procedure which are:
    • the outer packaging of the medicinal product;
    • the immediate packaging of the medicinal product; and
    • the package leaflet for the medicinal product.

Further detail is available on the MHRA website here.

21 October
MHRA updates information on the combined review process for clinical trials

The MHRA has updated information on the combined review process.

The combined review service, formerly known as Combined Ways of Working (CWoW), will become the way that all new Clinical Trials of Investigational Medicinal Products (CTIMPs) applications are prepared, submitted and reviewed from 1 January 2022. Combined review offers a single application route and co-ordinated review leading to a single UK decision for Clinical Trials of Investigational Medicinal Products (CTIMPs).

The service is open now to all CTIMP sponsors and applicants. Any new CTIMP applications planned over the coming weeks or months should be submitted via combined review. To register, make a submission, or to get more information, please refer to the Health Research Authority website.

More information is available on the MHRA website, here.

1 November
New guidance document published on the involvement of patient organisations in the assessment of patient information HMV4

The new guidance document entitled  Involvement of patient organisation in assessment of patient information HMV4 s valid with effect from 1 November 2021.

It sets out, among other things, the responsibilities and the procedure, and gives patient organisations further instructions on the criteria to be examined in the patient information.

The involvement of representatives from patient organisations in the assessment of patient information in applications for authorisation/indication extensions for human medicinal products was trialled in a pilot phase (2018–2020).

Due to positive experiences from the pilot phase, all applicants will now have the option of involving patient organisations in the assessment of patient information as required, for the following application types:

  • New authorisation of human medicinal product with new active substances under:
    • the standard procedure (NA NAS)
    • the fast-track procedure (NA NAS FTP)
    • the procedure with prior notification (NA NAS PPN)
  • Authorisation extensions involving revision of the medicinal product information (MPI), and
  • Type II changes involving revision of the MPI or indication extensions.

Source: Swissmedic website

25 November
Application for a Manufacturer’s/Importer’s Authorisation

HPRA has posted an updated version of the application form for a Manufacturer’s/Importer’s Authorisation.

17 November
Outcome of the process – Public consultations on proposed fees 2022: Human medicines, Compliance activities, Medical devices and Veterinary medicines

The HPRA received no responses on the Human Medicines, Compliance fees and Medical Device fee consultation and no responses on the Veterinary Medicines consultation.

Consequently, as no responses were received, HPRA proposes to submit the fee structure as
outlined in the original consultation document to the Minister for Health and the Minister for Agriculture, Food and the Marine for approval.

Suurce: HPRA Website

European Medicines Agency
24 November
Use of real-world evidence in EU medicines regulation 

As outlined in an article published in the journal, Clinical Pharmacology & Therapeutics, the vision of European reguators is to enable the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation and supervision of medicines in Europe by 2025

The authors emphasise that delivering this vision, anchored in the Network Strategy to 2025, will support the development and use of better medicines for patients. The creation of the Data Analytics and Real World Interrogation Network (DARWIN EU) will be key to delivering this vision when it is launched in early 2022.

  • The article explains plans to establish methods and standards for high-quality collection and use of RWE, in cooperation with stakeholders including patients, healthcare professionals, industry, regulatory and public health agencies, health technology assessment bodies, payers, and academia.
  • According to the authors, it will be important to advance the debate on the value of RWE compared to randomised clinical trials (RCTs), the gold standard to demonstrate efficacy of a medicine. The vision is that RWE and RCTs should be seen as complementary, each having strengths and weaknesses, with their relative importance depending on the regulatory question.
  • A rigorous and systematic approach to learning from doing will help to identify and establish the use-cases in regulatory decision-making for which RWE will add most value.

The EMA has also contributed to an another article also published in the journal, Clinical Pharmacology & Therapeutics that examines when and how RWE was used to support marketing authorisation applications for new products and extensions of indications, submitted to the Agency in 2018 and 2019.

The retrospective analysis shows that 40% of initial marketing authorisation applications and 18% of applications for extension of indication for products currently on the market contained RWE. The article describes the characteristics of RWE included in these applications and identifies areas where further research is required.  

Source: EMA website

12 November
Mandatory registration of new sites for centrally authorised medicinal products from November 2021

As per page 1 the EMA post-authorisation procedural advice for users of the centralised procedure, from 1 November 2021, the registration of new sites and organisations for centrally-authorised medicinal products in Organisation Management Service (OMS) is mandatory prior to the associated regulatory submissions to the Agency (e.g. transfer of the marketing authorisation, addition of a manufacturing site etc.).

The EMA emphasises the importance of these site/organisation registrations in OMS prior to pre- and post-authorisation submissions, in order to avoid any delay in the start of these procedures, as this would constitute a validation blocking issue.

Source: European Medicines Agency

European Commission
6 November
Genetically Modified Organism (GMO) aspects for investigational medicinal products

The commission has posted updated versions of the following documents:

Updated version – Common Application form for clinical research with human cells genetically modified

Updated version – Good Practice on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified

Source: Europa website

3 November
Updated Guide to Batch-Specific Requests for Human Medicines published

Version 4 of the above updated guide has been published. It states that the MA holder may be required to send a Healthcare Professional Communication/Caution-inUse (CIU) letter to the professions, or it may be necessary for such a letter to accompany each
unit of the batch affected. A sample template of such a letter is provided.

Here you can view the track changed and clean versions of the guidance.

Source: HPRA website

2 November
Outcome of the public consultation on the proposal for Clinical Trials fees 2022

The conclusion of the above consultation is:

Overall, the responses were positive to the new fees. When proposing the new fees, the HPRA reviewed the fees in other Member States where they are published. While HPRA are sympathetic to the view of not applying a fee to academic and non-commercial trials, we consider it appropriate to introduce a small fee to cover some of the time and assessment work involved.

HPRA proposes to submit the fee structure as outlined in the original consultation
document to the Minister for Health for approval.

Source: HPRA website

25 October
Guideline for the registration of Drug-Medical Device and Medical Device-Drug combination products

The NPRA has published the 4th Edition (6th October 2021) of the above guideline which has been fully enforced since 1 st July 2019.

This guideline serves as guidance for the submission of registration application of drug-medical device/ medical device-drug combination products, and change/variation application.
Drug-medical device/ medical device-drug combination products are regulated according to the classification whether as drug or medical device based on the primary mode of action (PMOA).

The scope of this guideline includes information relating to dossier requirements, procedures for submission of combination products registration and change/variation

Source: NPRA website

15 November
TGA consults on potential regulatory options for ‘export only’ biologicals

The TGA is conducting a public consultation on potential options for the regulation of biologicals manufactured in Australia for ‘export only’ (not for local supply).

Currently, biologicals included in the ARTG can be exported, but cannot vary from the product supplied in Australia i.e. ‘export only’ biologicals cannot have different indications, release specifications, or labels to the product approved by the TGA, even if the importing country has assessed and approved the product independently.

TGA is seeking feedback from consumers, healthcare professionals and the biologicals industry on:

  • potential options for the creation of a new regulatory pathway for ‘export only’ biologicals
  • suitability of current standards and GMP requirements for biologicals for ‘export only’ goods.

The current classification system for biologicals, which determines the evidence required to
satisfy the TGA of safety, quality and efficacy, is not considered suitable for export only

The objectives of the proposed export only regulatory scheme for biologicals are:

  • to minimise regulatory burden on biologicals that are for export only
  • to bring the biologicals framework into alignment with how other export only therapeutic products are regulated by the TG

The options for the proposed ‘export only’ pathway are:

  • Option 1: Automatic inclusion of export only biologicals for sponsors with a‘parent product’ included in the ARTG. If the Sponsor has an existing product includin the ARTG, with the same active ingredient and principal manufacturing site, they cancertify compliance against specific requirements, with automatic inclusion in the ARTG.This option is designed to give flexibility to current sponsors of biologicals included inthe ARTG.
  • Option 2: Abridged pre-market assessment of export only biologicals. Submission of documentation addressing specific requirements for an abridged premarket assessment by TGA prior to inclusion on the ARTG. This option does not require an existing similar product to be included on the ARTG and caters for sponsors who do not have an entry on the ARTG.
  • Option 3 Status Quo. The current requirement for biologicals, based on product classification, including GMP and premarket assessment.

Consultation start date: 15 November 2021 

Consultation end date: 20 December 2021

You can get further information and respond to the consultation via the TGA Consultation Hub.

Source: TGA website

23 November

The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to:

  • company
  • dossier and product
  • regulatory activity
  • regulatory transaction

Health Canada has updated the Regulatory Enrollment Process page on its websitewith a revised REP guidance document. The validation rules for the transactions containing the REP Company XML file have been removed.

Regulatory Enrollment Process page updated
5 November
Health Canada update on filing submissions electronically

Health Canada has update its page on electronic submissions. It seems that the only update on the page is under the section ‘eCTD format only’ and concerns clinical trial applications.

Source: Health Canada website

29 October
Health Canada publishes Guidance for market authorisation requirements for COVID-19 drugs: Overview

Health Canada has published guidance for market authorisation requirements for COVID-19 drugs: Overview

The availability of safe, effective and high-quality drugs is a key public health measure of the COVID-19 response, providing a potential means to reduce the spread and the severity of disease and address its social and economic consequences.

The provides guidance to drug manufacturers seeking authorisation for their drug manufactured, sold, or represented for use in relation to COVID-19. It should be read along with the guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. The guidance explains recent changes to the regulatory process for new COVID-19 drugs.

It is important to note that this guidance document does not apply to COVID-19 vaccines.

Source: Health Canada

Source: STAT News

17 November
Cofepris becomes a member of the ICH

Mexico has become the first Spanish-speaking country to be a member of the ICH. On 17 November, Cofepris, the Mexican drug regulatory agency was approved as a member of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceutical Products for Human Use (ICH).

This achievement represents an advance for the country, since having membership contributes to promoting public health, encouraging new technologies and the introduction of new medicines accepted worldwide, which will improve access and availability for patients.

By being a member of the ICH, Mexico becomes a strategic and competitive destination to carry out clinical trials, eliminating the need to duplicate tests carried out during the research and development of new drugs, with processes homologated to those of Europe and countries such as the United States, Canada and Japan.   

In the Americas, only Canada, the United States, and Brazil are ICH members. After acceptance by the assembly, Mexico becomes the fourth country on the continent to be a member, as well as the first Spanish-speaking nation.

Source: Cofepris website

16 November 2021
Highly anticipated Cures 2.0 bill introduced

U.S. Reps. introduced their highly anticipated, bipartisan Cures 2.0 legislation that some leading health care organisations are calling a potential “game changer” in how the U.S. conducts biomedical research going forward.  

Included in the 173-page bill designed to revolutionise how the U.S. provides care to patients are several provisions aimed at speeding up the delivery of groundbreaking, new – and potentially lifesaving – cures, treatments and innovations to those who need them most. 

The legislation would also create an entirely new agency aimed at ending some of the world’s most difficult diseases – such as cancer, diabetes, ALS, Alzheimer’s and more. The so-called Advanced Research Projects Agency for Health, or ARPA-H, would be housed within the National Institutes of Health (NIH) and tasked with finding new cures and treatments to a slate of illnesses that affect tens of millions of Americans across the country.

In addition to establishing a new advanced research agency for health, the legislation would also authorise the full $6.5 billion the administration has requested to run the agency for the first three years. 

Under the terms of the Cures 2.0 legislation, once created, ARPA-H would be run by a relatively small number of program managers who would each be given a high degree of autonomy to choose which high-risk, high-reward projects to pursue.


12 November
FDA announces availability of Study Data Technical Conformance Guide – Technical Specifications Document

The FDA is announcing the availability of a Study Data Technical Conformance Guide and an update to the Data Standards Catalog (formerly the Study Data Standards Catalog). The Study Data Technical Conformance Guide supplements the revised draft guidance for industry “Providing Regulatory Submissions in Electronic Format—Standardized Study Data” and provides specifications, recommendations, and general considerations on submitting standardised study data using FDA supported data standards specified in the Data Standards Catalog.

  • The guide does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
  • You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Source: FDA website

29 October

The FDA launched its new NextGen Portal for reporting manufacturing volume data for drugs and biologics under the CARES Act, together with two guidance documents to assist registrants in complying with the reporting requirements.

27 October
Public-private partnership launched to accelerate gene therapies for rare diseases

The National Institutes of Health (NIH) and U.S. FDA unveiled a public-private partnership aimed at accelerating gene therapies for the roughly 30 million Americans living with a rare genetic disease.

With $76 million over five years, the Bespoke Gene Therapy Consortium (BGTC) will fund research into improving manufacturing processes and standardising methods for preclinical testing of gene therapies. The initiative, which includes 10 pharmaceutical companies and five nonprofit organisations, will also support four to six clinical trials, each focused on a different rare disease.

The BGTC will focus on projects that illuminate the basic biology of the adeno-associated virus, or AAV, one of the most common vehicles, or vectors, for delivering genes to where they’re needed. The effort highlights a longstanding limitation of gene therapy: effectively getting therapeutic genes into target cells.

Gene therapy researchers turned to AAVs in the 2000s after a patient named Jesse Gelsinger died from an immune response to an experimental gene therapy that used an adenovirus as a vector. Unlike adenoviruses, AAVs are adept at evading the immune system, making them much less likely to provoke a dangerous response.

Joni Rutter, acting director of the National Center for Advancing Translational Sciences said that one of the initial aims of the new consortium is to fund studies that will more fully examine all the different flavors of AAVs. Some target the liver and the central nervous system, others target other organs and tissues. Some are big enough to carry CRISPR genome-editing machinery, others are better suited to smaller genetic payloads, like antisense oligonucleotides. And different AAVs interact with the immune system in different ways. “We think we need to learn a little bit more about the biology,” said Rutter.

30 November
HPRA Medical Devices Newsletter – Issue 54 – November 2021

HPRA has published issue 54 of its Medical Devices Newsletter, packedwith useful information. It includes information that should be useful to anyone in the EU. Amongst the topics included in the newsletter are the following:

  • IVDR transition and implementation
  • Review of Medical Device Compliance/Inspection Activities – on the transfer of the inspection activities into a newly established Medical Devices Inspection team within the Assessment & Surveillance section of the Medical Devices Department. Certificates of free sale activities have transferred into the Regulatory Support team within the Regulatory & Policy section
  • Eudamed Update – on the launch of The UDI/Devices Registration and NBs and Certificates modules are now available for use
  • Certificates of Free Sale – on the changes that the HPRA has made recently, to the application process including new contact points and two new application forms.
  • Clinical Investigations – Process and Guidance Updates

Source: HPRA website

22 November
Stakeholder survey on in-house manufacturing of in vitro diagnostic medical devices

HPRA is conducting a survey to collect information about how in-house manufacturing of in vitro diagnostic medical devices will be impacted by the In Vitro Diagnostics Regulation (IVDR). medical laboratory scientists and personnel who work with in vitro diagnostic medical devices are invited to complete the survey, which is available here.

The survey will remain open until Friday, 17 December 2021

An in-house device (IHD) is a device that is manufactured within a health institution established in the European Union that meets all conditions set in Article 5(5) of the IVDR and is used within that same health institution. Laboratory-developed tests are considered and now referred to as ‘in-house devices’ where they meet the definition of an IVD, as defined in Article 2(2) of the IVDR, and meet the conditions of Article 5(5).

Source: HPRA website

4 November
Updated guidance on export certificates, including certificates free sale for medical devices

The HPRA has published updated information relating to export certification, including information about certificates of free sale for medical devices.

In this update, the HPRA has:

  • Provided an overview of the legal basis for issuing certificates of free sale;
  • Clarified the process for applying for certificates of free sale under Directive 93/42/EEC (MDD) and Regulation 2017/745 (MDR);
  • Developed a checklist to assist stakeholders when applying for a certificate of free sale.  

To view these updates in more detail please visit the Export Certificate webpage.

Source: HPRA website

29 November
Premarket Submissions: Selecting and Preparing the Correct Submission

The Center for Devices and Radiological Health (CDRH) has updated the Premarket Submissions page to make it easier to find content on premarket submissions.

The electronic submissions Template and Resource (eSTAR) now includes De Novo content consistent with the De Novo final rule which was published on 5 October 2021 and is effective from 3 January 2022 . The De Novo template is being provided for viewing purposes so applicants can familiarise themselves with the content.

Applicants may voluntarily use the eSTAR to prepare a De Novo request, which can be submitted to CDRH on or after January 3, 2022.

Source: FDA website

4 November
Content of Premarket Submissions for Device Software Functions

This draft guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are functions that meet the definition of a device under section 201(h) of the FD&C Act.

The recommendations in this guidance document concern device software functions,
including software in a medical device (SiMD) and software as a medical device (SaMD).

When final, this document will replace FDA’s Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices3 21 issued on May 11, 2005, and it will update FDA’s thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions.

The guidance identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. The recommendations in the guidance also may help facilitate FDA’s premarket review. The guidance describes information that would be typically generated and documented during software development, verification, and design validation.

Source: FDA website

26 November

The TGA has published several guidance documents as detailed in the table below:

GuidanceVersion noSummarySource
Manufacturer’s declaration
of conformity for Class I and Class 1 IVD
medical devices, export-only Class I and
Class 1 IVD medical devices, and Class I
and Class 1 IVD system or procedure
Version 1.2,
November 2021
Update to include guidance relating to requirements for system or procedure packs.
This document is designed to assist manufacturers in completing the relevant Declaration of Conformity and to assist sponsors confirming that documentation prepared by the manufacturer is complete.
TGA website
declaration of conformity for system
or procedure packs (other than
Class I or Class 1 IVD system or
procedure packs)
Version 1.0, November 2021This document is to assist manufacturers of system or procedure packs in completing the declaration of conformity made under clause 7.5 of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002, for system or procedure packs (other than a Class I or Class 1 IVD system or procedure pack). Separate guidance is available to assist manufacturers of Class I or Class 1 IVD system or procedure packs to make this declaration using a different template.TGA website
System or procedure packs
Guidance for sponsors, manufacturers and
Version 1.0, November 2021From 25 November 2021, new regulatory requirements apply to medical devices that meet the definition of ‘system or procedure packs’ and are supplied using the special conformity assessment procedure regulatory pathway.

The new regulations only apply to system or procedure packs that are supplied using the special conformity assessment procedure.

This guidance:
1) aims to assist sponsors and manufacturers of these medical devices, by explaining their obligations under the new regulations and transitional arrangements for any of these medical devices included in the ARTG before 25 November 2021.

2) also describes the various regulatory mechanisms that are in place to support the supply of various types of system or procedure packs by charities and other organisations (such as schools). Refer to Appendix 1 of this guidance for more information.
TGA website

22 November

The TGA has published a number of updated guidance documents (concerning the reclassification of specific groups of medical devices) which provide guidance on transitional arrrangements and obligations as detailed in the table below. TGA has also published an FAQ on the reclassification of these devices.

Guidance on the transitional
arrangements and obligations
Version noSummarySource
Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems Version 1.1, Nov 2021From 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices. TGA website
Reclassification of medical devices that administer medicines or biologicals by inhalation Version 1.1, Nov 2021From 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb). TGA website
Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin Version 1.1, Nov 2021From 25 November 2021, some medical devices that are substances for introduction into the body require reclassification. The new regulatory requirements will also include:
-more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
-conformity assessment documents demonstrating procedures appropriate for their classification
-a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.
TGA website
Reclassification of spinal implantable medical device Version 2.1, Nov 2021From 25 November 2021, some spinal implantable medical devices will require reclassification. The new regulatory requirements will also include the assessments stated in the box above. TGA website
12 November
Adverse event reporting for medical devices -updated sponsor requirements

Version 2.1 of the guide for adverse event reporting is now available.

Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 will alter sponsor requirements device adverse event reporting.

It is an automatic condition of inclusion under 5.7 of the Therapeutic Goods (Medical Devices) Regulations 2002 that sponsors of a medical device report adverse events or near adverse events to the TGA Incident Reporting and Investigation Scheme (IRIS).

It is important to note that the act of reporting a problem is not an admission of manufacturer, sponsor, user, or patient liability for the event or its consequences.

In version 2.1, the date of final adverse event report is amended and additional information in line with amendments to the Therapeutic Goods (Medical Devices) Regulations 2002.

Sponsors must make a final report within one hundred and twenty (120) calendar days of the submission of an initial report.

Suurce: TGA website

Medical device incident reporting (MDIR) guide -Sponsor guide to MDIR 2021

Version 2.1 dated 29 October 2021 of the above guide is now available. This document is a user guide for sponsors to the  Medical Device Incident Reporting (MDIR/9 system. It outlines the initial steps to access the MDIR system and then describes how to use the system, with step by step instructions and examples as required.

This update concerns the inclusion of the final report and additional information
requirements following amendments to the Therapeutic Goods (Medical Devices)
Regulations 2002.

Source: TGA website

11 November
Guidance on the reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin, published

The purpose of this guidance is to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and it outlines transitional arrangements to help comply with new regulations.

From 25 November 2021, some medical devices that are substances for introduction into the body will be required to be reclassified.

The new regulatory requirements will also include:

  • more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
  • conformity assessment documents demonstrating procedures appropriate for their classification
  • a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.

The classification of medical devices that are substances for introduction into the body determines the safety and performance requirements to be demonstrated to meet regulatory requirements.

4 November
Custom made medical devices – Annual reports

Manufacturers and sponsors of custom-made medical devices must supply an annual report detailing all of the custom-made medical devices they have manufactured and/or supplied within the preceding 1 July – 30 June financial year. The report must be submitted in the approved format by 1 October of the following financial year.

To submit an annual report:

  1. Download the custom-made medical device annual report spreadsheet template: Annual Reporting Form – Custom-made medical devices (Excel,13kb)
  2. Submit the report using the online form: Annual Reporting Form – Custom-made medical devices

Source: TGA website

19 November

Swissmedic publishes the “Visible” magazine on its website. The focus of the most recent edition, the fourth, is how Swissmedic manages change.

Amongsthe other interviews, it is worthwhile reading the interview with Karoline Mathys, Head of Market Surveillance st Swissmedic, to understand the implications of the failed ­Framework Agreement with the EU, interdependencies with the EU regulations, collaboration with the European authorities and Switzerland’s security of supply.

22 November
Antibody test that produces results in ten minutes

A joint research group from Sinagpore and the US has developed a rapid point-of-care test for the detection of SARS-CoV-2 neutralising antibodies (NAbs).

As part of a body’s natural immune response, NAbs are generated by either exposure to the virus or a vaccine. For effective prevention of viral infections, NAbs must be generated in sufficient quantities. The number of NAbs present in individuals indicate if they possess protective immunity to the virus and their probability of experiencing severe outcomes should they be infected. NAb testing can determine whether vaccinated individuals should be considered for booster shots for additional protection against the virus.

The detection of SARs-CoV-2 NAbs is still generally conducted at hospitals and specialised diagnostic laboratories. The development of a more efficient means of testing better allows for immediate point-of-care testing and mass monitoring for events or workplaces, specific localities, high traffic points, and critical points of entry such as immigration checkpoints.

To perform the test, a user mixes a drop of fingertip blood with the reaction solutions and places it on a paper strip, before inserting it into a portable reader device that will detect the NAb signals and reflect the results. This test offers up to 93% accuracy. Currently, no similar NAb tests are commercially available within Singapore or elsewhere.

Further development of the test is underway for assessment aand approval by regulatory authorities and manufacturing for public use. The team that has developed the tests at has also spun off a biotech start-up, Thrixen, that is developing the test into a commercially ready product.

Source: Med-Tech Innovation News

17 November
US FDA grants first approval for a VR system to treat chronic lower back pain

The FDA has approved a virtual reality device to treat lower back pain, offering up an opioid-free alternative to many current pain management regimens.

The newly approved EaseVRx device comes from AppliedVR. It uses cognitive behavioral therapy and other therapeutic techniques to guide patients through games, lessons and exercises to reduce their chronic back pain. The immersive software is loaded onto a VR headset and used by patients in solo, at-home sessions every day for eight weeks, with sessions ranging from two to sixteen minutes in length.

With the FDA’s de novo clearance, AppliedVR can now begin marketing the device across the U.S. It’s indicated for prescription use only by patients aged 18 and older who have been diagnosed with moderate to severe back pain lasting longer than three months.

Sources: Fierce Biotech, FDA website

20 October
Partnership develops app for people with Inflammatory Bowel Disease

Ampersand Health and Calpro AShave announced a partnership integrating the CalproSmart Self-Test into Ampersand’s My IBD Care, a behavioural science based digital therapeutic app for people with inflammatory bowel disease (IBD). 

The integration will allow patients to initiate the CalproSmart Self-Test from home and share the results in the app for clinicians to review alongside lifestyle, symptom and wearable data on a single dashboard portal that provides a 360 view of a person’s condition. This enables greater patient autonomy and self-management, as well as a more accurate view of greater disease progression for clinicians.

Source: Med-Tech News

25 November

ICH’s Working Groups have continued to progress their activities virtually and the Assembly was recently updated on the status of ICH’s Working Groups. The Assembly noted significant milestones reached recently by several Working Groups including the following:

Step reachedGuideline or documentWhen reached
Step 4Electronic Common Technical Document (eCTD) v4.0 Question & Answer Document v1.6 and eCTD v3.2.2 Question & Answer Document v1.32November 2021
Step 4ICH E8(R1) Guideline on General Considerations for Clinical StudiesOctober 2021
Step 2ICH Q9(R1) draft Guideline on Quality Risk Management (QRM) which is intended to provide important additional guidance on four specific areas: the levels of subjectivity in risk assessments and in QRM outputs; the product availability risks; the lack of understanding as to what constitutes formality in QRM work; and the lack of clarity on risk-based decision-making.November 2021
Step 2CH M7(R2) draft Guideline and Addendum on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk which is intended to provide useful information regarding the acceptable limits of known mutagenic impurities/carcinogenic and supporting monographsOctober 2021
Step 2ICH Q13 draft Guideline on Continuous Manufacturing of Drug Substances and Drug Products July 2021

Source: ICH website

Institute for Clinical and Economic Review (ICER)
16 November

According to a recently published ICER report, of Unsupported Price Increases (UPI) of prescription drugs in the US, among the top drugs with price increases in 2020 that had substantial effects on US spending, ICER determined that 7 out of 10 lacked adequate new evidence to demonstrate a substantial clinical benefit that was not previously known.

A selection process produced a total of 10 prescription drugs, for which ICER then determined whether, during 2019 and 2020, there was any new moderate- or high-quality evidence that these treatments provide a substantial improvement in net health benefit beyond what was previously known

The 2020 unsupported price increases on these seven treatments, even after pharmaceutical rebates and other concessions, cost the US health system an additional $1.67 billion beyond what would have been spent if their net prices had remained flat.

Thee seven therapies, in order of the impact of their net price increases on US drug spending, are: Humira® (adalimumab, AbbVie), Promacta® (eltromobopag, Novartis), Tysabri® (natalizumab, Biogen), Xifaxan® (rifaximin, Bausch Health), Trokendi XR® (topiramate, Supernus Pharmaceuticals), Lupron Depot® (leuprorelin, AbbVie), Krystexxa® (pegloticase, Horizon Pharmaceuticals).

The three therapies assessed that did have new important positive clinical evidence were Venclexta® (venetoclax, AbbVie), Cimzia® (certolizumab pegol, UCB), and Entresto® (sacubitril/valsartan, Novartis); the evidence used to justify Entresto’s price increase was the same evidence used to justify its prior year’s price increase. Importantly, however, ICER’s determination that new evidence exists for these three treatments should not be interpreted to mean that the new evidence justifies the level of price increase; a full cost-effectiveness assessment was not conducted.

Source: ICER website

Image by Gerd Altmann from Pixabay