International regulatory news in brief

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

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

14 June
Change to Patient Leaflet readability test from end December 2024

Currently, a Readability Test for Human Medicinal Products must be submitted in line with the Regulation on Packaging Information, Instructions for Use and Follow-up of Human Medicinal Products. Until now, a Readability Test conducted abroad and the submission of its Turkish translation were considered valid.

  • As of 31 December 2024, the Readability Test conducted abroad and its Turkish translation will not be accepted, and the readability test conducted domestically must be submitted.
  • For medicinal products for human use whose registration process is ongoing and whose registration has not been issued until 31 December 2024; Even if the Readability Test conducted abroad and its Turkish translation have already been submitted, a readability test conducted domestically must be submitted as of 31 December 2024.

Source: TITCK

11 June
Updated guides on packaging and excipients

The following guides have been updated and published:

  • Guide on the Packaging Information and Instructions for Use of Medicinal Products for Human Use,
  • Guide on the Readability of the Packaging Information and Instructions for Use of Medicinal Products for Human Use, and
  • Guide on Excipients in the Packaging Information and Instructions for Use of Medicinal Products for Human Use

You van view the revision 12 of the guide here.

Source: TITCK

5 June
Update to the ‘Notification of Applicants’ annex of the CTD guide

In accordance with the “Licensing Regulation for Human Medicinal Products” published in 2021 which determines the procedures and principles for the submission of human medicinal product license applications made to TITCK in CTD format, the “Notification to Applicants” annex of the CTD Guide has been updated and published. You can view all of the Annexes from this link.

Source: TITCK

30 May
For the attention of pharmaceutical companies RD/2024/5/1 commencing the marketing authorisation application process

In accordance with the first paragraph of Article 12 of the Regulation on the Licensing of Medicinal Products for Human Use, applications for authorisation can be made by applicants throughout the year.

  • The authorisation process can only be initiated in February, May, August and November, taking into account the Agency’s authorisation capacity.
  • As of 3 April 2023, within the scope of the transition to e-CTD, notification of the initiation of the authorisation process for the marketing authorisation applications for which an application form was filled out from the EBS-ESY system which were included in the calendaring list by the Preliminary Examination (CTD) Unit in accordance with the ‘Guideline on the Scheduling Processes of the Marketing Authorisation Applications of IRD-KLVZ-13 Medicinal Products for Human Use’, notification will be sent by e-mail to the registered e-mail addresses of the user who applied for the marketing authorisation and the person defined in the system as the authorised person of the company, without an official letter.
  • With the May 2024 schedule, the notification to be made by the Preliminary Examination (CTD) Unit that the licensing processes have been initiated will be simultaneously reflected on the company application screen (Homepage/Applications/e-CTD Licence Applications) as well as being sent by e-mail to the registered e-mail addresses of the person or persons defined in the system as authorised on behalf of the licence applicant.

Source: TITCK

23 May
Guideline on Auxiliary Medicinal Products for Human Use

The Guideline on Auxiliary Medicinal Products for Human Use was prepared within the scope of the “Regulation on Clinical Research of Medicinal Products for Human Use” and entered into force on 20.05.2024.

The purpose of this guideline is to clarify the definition and provide information on the use of ancillary human medicinal products in accordance with national and international standards.

You can view/download the guideline here.

Source: TITCK

4 June
Swiss Public Assessment Report (SwissPAR) survey

Since the revision of the Therapeutic Products Act in 2019, Swissmedic has published additional information on medicinal products, including the Swiss Public Assessment Report (SwissPAR).

  • The SwissPAR summarises Swissmedic’s approval decisions on human medicinal products with new active ingredients. 
  • 5 years after the introduction of the SwissPAR, Swissmedic would like to know whether it meets the expectations of readers and where there is potential for improvement.
  • The SwissPAR is aimed at a broad readership, your feedback is important to Swissmedic.

Participation is anonymous and takes about 5 minutes. You can participate in the survey here.

Source: Swissmedic

Changes to the Guidance document Time limits for authorisation applications

The international Project Orbis and Access Consortium procedures have been added to the updated Guidance document Time limits for authorisation applications (Ver 7.0) which is effective from 1 June 2024.

  • The overview of time limits has also been restructured so that it is clearer which procedures are fast-tracked.
  • The integration of international procedures into the Guidance document includes a revision of section 5.1 “Procedure period”.
  • A new subsection 5.1.3 “International procedures” has been added.
  • The time limits for international procedures have also been added to the overview of time limits in Annex 1.
  • The overview of time limits has also been restructured to organise the procedures by standard time limits, fast-track time limits and by national and international procedures.
  • Various editorial changes have also been made as part of the update to the Guidance document.

The revised Guidance document Time limits for authorisation applications is valid with effect from 1 June 2024.

Source: Swissmedic

Changes to the Guidance document Temporary authorisation of human medicinal products

Medicinal products for identifying, preventing or treating a disease that is life-threatening or could result in disability can be authorised temporarily by Swissmedic.

  • Application of the fast-track procedure for temporary authorisations enables medicinal products with a major therapeutic benefit to be made available to affected patients more quickly.
  • This revision of the scope for temporary authorisations makes these possible for human medicinal products with a known active substance, provided that all criteria according to Art. 9a TPA in conjunction with Art. 18 TPLO are met.
  • The restriction that the innovative aspect of the new authorisation with known active substance must be an indication extension has been removed from the scope.
  • The revised Guidance document  Temporary authorisation for human medicinal products (Ver 15.0)  is effective from 1 June 2024.

Source: Swissmedic

Changes to the Guidance document Meetings for applicants for authorisation procedures

As part of a pilot, Swissmedic is now offering Preliminary Decision Clarification Meetings for applications for new authorisation or variation of the indication of medicinal products for human use with a new active substance (NAS).

  • During the Preliminary Decision Clarification Meeting, applicants have an additional opportunity for dialogue with Swissmedic to clarify any questions or anything that is unclear regarding the preliminary decision.
  • Further information on how to request a pilot Preliminary Decision Clarification Meeting and its structure can be found in the Annex to the Guidance document Meetings for applications for authorisation procedures
  • Swissmedic has revised the Guidance document Meetings for applications for authorisation procedures, providing further clarification, particularly regarding the content of the Pipeline Meeting, and making editorial changes.
  • The revised Guidance document Meetings for applications for authorisation procedures (Ver 3.0) is effective from 1 June 2024.

Source: Swissmedic

Changes to the Guidance document Variations and extensions HAM

The rules on issuing new packaging codes are being simplified, meaning that Swissmedic will issue significantly fewer new codes in the future.

  • This simplification will apply to applications received by Swissmedic from 1 June 2024.
  • Section 9.3 Issuing of a new packaging code in the Guidance document (WL) Variations and extensions HAM has been revised accordingly.
  • In addition, redundancies in sections 9.1 Issuing of a new authorisation number and 9.2 Issuing of a new dosage strength number have been deleted.
  • With the increase of the flat fee for indication extensions to CHF 25,000 and lowering of the maximum cost cap to CHF 30,000, Swissmedic will in future not subsume fees for multiple applications.
  • Numbers 7.8, 7.9 and 7.14 in the document Questions and answers on variations and extensions HMP have been revised or deleted accordingly.
  • It has been clarified in section 1.1.7 Multiple application of the Guidance document Variations and extensions HAM that each variation must be ticked individually in the corresponding application submission form.
  • The revised Guidance document Variations and extensions HAM and the revised document Questions and answers on variations and extensions HMP (Ver 9.0) is effective from 1 June 2024.

Source: Swissmedic

29 May
Quicker access to promising cancer treatments via Project Orbis

Swissmedic has participated in Project Orbis since 2020. Swissmedic experts scientifically evaluated the impact of the programme on the submission and review processes for medicinal product authorisations in Switzerland. Their aim was to assess its effects from Swissmedic’s point of view. Some of the main points from the review are:

  • The analysis published in the scientific journal The Lancet Oncology compares submission data, the rate of positive or negative authorisation decisions and the approved indications for applications submitted to Swissmedic and the FDA, both within and outside Project Orbis.
  • 31 MAAs for new active substances and indication extensions for oncology products that were submitted within Project Orbis between 1 Jan 2020 and 31 Dec 2021 and compared with 41 MAAs processed outside Project Orbis (non-Orbis MAAs).
  • For the analysis of throughput times, authorisation decisions up to 30 June 2022 were evaluated, while the comparison of approvals or rejections took into account the oncology marketing authorisation applications submitted and evaluated outside Project Orbis between January 2009 and December 2018.
  • The submission gap between the date of submission to the reference authority (the FDA) and submission to Swissmedic was 33 days for Orbis MAAs versus 168 days for non-Orbis MAAs. Review time3 at Swissmedic was 235.5 days for Orbis MAAs versus 314 days for non-Orbis MAAs.
  • As regards new applications for new active substances (NA NAS), Swissmedic and FDA decisions were identical in 88% of Orbis MAAs and in 82% of non-Orbis MAAs.
  • The NA NAS approval rate in Switzerland – even taking into consideration the ten-year comparison before Orbis – is therefore constant at between 82% and 88%.
  • Swissmedic approval rates (NA NAS and indication extensions) were very similar for the applications submitted within and outside Project Orbis (77% for Orbis MAAs and 76% for non-Orbis MAAs).
  • The authorities thus tended to diverge in their decisions as regards indication extensions more than as regards NA NAS applications.
  • Interpretation of the results shows that participation in Project Orbis significantly reduces submission and review times for MAAs in the oncology area at Swissmedic and has increased the consistency of approval decisions between the two authorities.
  • The initiative contributes to making innovative cancer medicines available to patients in Switzerland sooner and more quickly.

Source: Swissmedic

15 May
Guidance: Apply for a licence to market a medicine in the UK

The MHRA has added a new webinar video on the established medicines licensing process. You can view it here.

Source: MHRA

13 May
Guidance: Good manufacturing practice and good distribution practice

The MHRA has updated the contact form accompanying this guideline.

Source: MHRA

30 April
The MHRA sets out its strategic approach to Artificial Intelligence

The MHRA has today set out its strategic approach to artificial intelligence (AI) via the publication of the Policy Paper entitled Impact of AI on the regulation of medical products.

As a science-led organisation, the MHRA has a key role to play in enabling the UK to be a science and technology superpower by 2030. The agency is considering the opportunities and risks of Artificial Intelligence (AI), which has been identified as one of the five critical technologies in the UK Science and Technology Framework, from three different perspectives.

1. As a regulator of AI products

2. As a public service organisation delivering time critical decisions

3. As an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties

The Policy Paper more detail on each of the above three perspectives.

Source: MHRA

17 April
Updated Guidance: Medicines MA Holders submission of nitrosamine risk evaluation, risk assessment and confirmatory testing

The following updates have been added to this guidance:

  • Updated information following the passing of the deadline for the submission of steps 1, 2 and 3.
    • The deadlines of the call for review (steps 1, 2 and 3) for medicines containing chemically synthesised and biological active substances have passed.
    • Any MAH that has not notified the MHRA about identified nitrosamine impurities should report them as a matter of priority in line with the CHMP’s Article 5(3) opinion as well as any updates to previous notifications, using the response templates and available reporting mechanisms previously established.
  • Guidance has been added for MAHs regarding step 2 submission requirements where nitrosamines are determined to be non-mutagenic.
    • For nitrosamine impurities that are classified as non-mutagenic based on in-vivo mutagenicity studies, the submission of step 2 confirmatory testing is not required, and these impurities should be controlled according to ICH Q3A and ICH Q3B guidelines.
    • To allow nitrosamine outcomes to be correctly recorded for each Marketing Authorisation, Marketing Authorisation Holders are asked to continue making step 2 submissions for these products. The cover letter should indicate that the identified nitrosamine is non-mutagenic and that therefore no test data are provided.
  • Additional guidance about lifecycle management is provided under the heading Lifecycle Management. MAHs are expected to continue to review and re-visit the outcome of the risk evaluation as and when new information becomes available. This includes:
    • Changes to known root causes which may also affect the product in question, including when a new Acceptable Intake (AI) limit is published for the product in question.
    • Changes in the product lifecycle that may require a revision of the risk evaluation and may change the outcome of the risk evaluation.

Further information is available at the link below.

Source: MHRA

Updated Guidance: Rolling review for marketing authorisation applications

For the above procedure, the email address used to request pre-submission advice has been replaced with

Source: MHRA

31 May
Parallel distribution guides

Revision 4 (31 May 2024) of the following guides are now available:

Checklist for Initial Notifications for Parallel Distribution

Checklist for Annual Updates for Parallel Distribution

Source: EMA

26 April 2024
Simultaneous National Scientific Advice 

On 19 April, the EMA held a webinar entitled Simultaneous National Scientific Advice – information and training webinar. You can view the webinar here. Information was provided under the following headings:

Welcome and opening remarks – 0:006:52

Overview of the SNSA concept –6:5311:00

Update on SNSA pilots to date 11:0131:54

SNSA procedural outline including recent changes –31:551:01:45

Planned next steps for SNSA – 1:01:461:31:40

Q&A and Discussion –1:31:412:16: 59

Closing remarks – 2:17:002:17:56

You can read more about SNSA in the following posts:

EU Simultaneous National Scientific Advice update (Aug 2021)

EU launches Phase 2 of the Simultaneous National Scientific Advice (SNSA) pilot (Nov 2022)

Source: EMA

23 April 2024
New recommendations to strengthen supply chains of critical medicines

EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.

These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which vulnerabilities in the supply chain have been identified.

Measures considered by the MSSG will be selected according to the risks posed to the supply chain and the type of medicine, and include:

  • Possible recommendations to marketing authorisation holders (MAHs) to increase manufacturing capacity and diversify the suppliers in the supply chain (e.g. through the addition of alternative manufacturing sites), and to monitor forecasts of supply and demand of medicines and available stocks in the entire supply chain.
  • Recommendations to certain actors in the supply chain, such as MAHs, and the European Commission to stockpile medicines to protect against fluctuations in demand or supply.
  • The possibility to request a MAH to establish a shortage prevention plan for medicines in the Union list of critical medicines. EMA will publish guidance and templates for shortage prevention plans in June 2024.
  • Provision of scientific and regulatory support to address vulnerabilities in the supply chain, including assistance to small and medium-sized enterprises.

Source: EMA

20 May
AEMPS launches an accelerated evaluation procedure for clinical trials

AEMPS has launched an accelerated evaluation procedure or fast-track with the aim of making Spain a more attractive environment for research into innovative medicines.

In general terms, Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use establishes the maximum deadlines for validation and evaluation of applications for authorization of trials submitted in the European Union. However, this procedure will allow the deadlines to be reduced for studies that meet the following criteria:

  • Be a phase I clinical trial.
  • Research advanced therapy medications.
  • Study seriously debilitating diseases or diseases that endanger the patient’s life and have no therapeutic alternative.
  • Submit through the EU clinical trials database  CTIS  ( Clinical Trial Information System )only in Spain.

In addition, the Drug Research Ethics Committee (CEIm) selected by the promoter must be one of the CEIm adhered to the fast-track procedure . The contact details of these CEIm are available in the Directory of CEIm accredited in Spain .

  • Those interested in taking advantage of this procedure must contact the AEMPS prior to submitting the application by writing to . This email will indicate the expected date of shipment, the evaluating CEIm and the characteristics of the trial: title, indication, investigational drug, population and additional information that justifies compliance with the requirements to access the accelerated evaluation procedure.
  • If you meet the requirements, once you have the fast-track acceptability approval from the AEMPS, the application will be evaluated within 26 days from validation . If it is not necessary for the agency to seek any clarification, a trial could be authorized by the AEMPS within a period of 31 days.
  • When submitting an application, it must be indicated in the accompanying letter that adherence to the fast-track procedure has been accepted by the AEMPS.

Source: AEMPS

6 May
AEMPS implements a new application for payment of clinical trial fees

AEMPS has implemented a new application to pay the fees for clinical trials in Spain. It becomes effective immediately.

  • The new procedure aims to make it easier for the user to pay the fee, reduce errors and reduce corrections.
  • The new method must be carried out through the ECMI portal, through the AEMPS headquarters
  • The Agency has prepared a manual for users with the aim of simplifying the payment of clinical trial fees through this new system, providing a series of instructions.

Payers will be able to complete the form with the information of the clinical trial for which they wish to pay the fee and begin the payment process. This action can be carried out through electronic payment or by downloading form 317 by bank transfer or cash.

Source: AEMPS

20 May
EMRN designated as WHO listed Authority

The European Medicines Regulatory Network (EMRN) as been designated as WHO Listed Authority (WLA) by the World Health Organization (WHO). This means that the network, composed of the European Commission, EMA and the 30 national authorities of the European Economic Area Member States, are recognised as meeting international regulatory standards, guidelines and practices.

Source: EMA

10 May
Guide to Combining Multiple Presentations of a Parenteral Product in One Product Authorisation

This document has been updated. Whilst there are several changes throughout the document, none of them appear to be major.

Here, you can view the track changed and clean (10 May 2024) versions of the document.

Source: HPRA

15 April
Updated Guide to Attainment of Qualified Person Status in Ireland

This guide has been updated substantially. Here, you can view the track changed and clean versions of the document.

Source: HPRA

3 April
Guide to Submitting a Request for Ireland to Act as RMS in a DCP for Human Medicines

This guide has been updated substantially. Here, you can view the track changed (29 Oct 2014) and clean (2 April 2024) versions.

Source: HPRA

Guide to Submitting a Request for a New National Application Procedure for a Human Medicinal Product

The above guide has been published and you can view it here.

Source: HPRA

11 April 2024
Parliament adopts its position on EU pharmaceutical reform

MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.

The legislative package, covering medicinal products for human use, consists of a new directive (adopted with 495 votes in favour, 57 against and 45 abstentions) and regulation (adopted with 488 votes in favour, 67 against and 34 abstentions)

You can read more about this here or in this blog post.

Source: European Parliament

13 May
Filing submissions electronically: Guidance documents, notices and supporting documents

On 10 MAy 2024, a small yet important update has been applied to this guidance under the heading Non-eCTD format only.

Source: Health Canada

2 May
Updated Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs)

This is an administrative changes update, done on 1 May 2024. You can view/download the updated document here.

Updates have been made to Regulatory Activity Types and Regulatory Transaction Descriptions and minor revisions have been made throughout the document.

Source: Health Canada

2 April
Organization and document placement for Canadian module 1

Health Canada has updated the organization and document placement for Canadian module 1 to reflect recent changes.

  • This document contains a table outlining the Canadian module 1 sections and subfolders, with a list of possible documents.
  • Sponsors must use this table to determine where to put documents provided as part of a regulatory transaction to Health Canada.
  • Health Canada will reject the transaction if sponsors don’t adhere to this structure.
  • Sponsors must use the table when filing in either electronic common document (eCTD) or non-eCTD formats for:
    • master files
    • disinfectants
    • clinical trial applications for human drugs
    • biologics and radiopharmaceuticals for human use
    • prescription and non-prescription pharmaceuticals for human use

The information in the table takes precedence over other publications concerning the placement of documents within a regulatory activity or transaction.

Due to ongoing changes in regulatory requirements, this list of documents isn’t exhaustive. This document is subject to periodic updates with additions, relocations or removals of documents. Sponsors are responsible for monitoring the posting date of the updated document.

Source: Health Canada

14 April
About the CDER Center for Clinical Trial Innovation (C3TI)

CDER established the CDER Center for Clinical Trial Innovation (C3TI) in April 2024 to enable and amplify innovative approaches to clinical trials that are designed to improve the efficiency and effectiveness of drug development. 

C3TI serves as a central hub to:

  • Facilitate coordination across CDER innovation programs to more easily engage in cross-program and cross-center collaborations. Existing CDER clinical development innovation programs will continue to operate according to their established processes, with C3TI serving to synthesize lessons learned across those programs.
  • Manage a demonstration program that will expand opportunities for sponsors of innovative clinical trials to interact with CDER staff and for these trials to serve as case examples to spur further innovation. More information on the demonstration program can be found on the C3TI Demonstration Program webpage. 
  • Provide CDER staff, drug developers, and other interested parties with a single CDER point of contact to assist with non-product-specific questions related to clinical trial innovation. 
  • Support knowledge sharing through various mechanisms, such as public workshops, discussion forums, communications and a website to centralize information on existing and new CDER clinical trial innovation efforts. More information can be found on the C3TI Knowledge Repository webpage.

Source: FDA

7 June
ANMAT is now a Regulatory Member of the ICH

During the ICH meeting of On June 4 and 5 held in the city of Fukuoka, Japan.  which ANMAT was approved to become a regulatory member.

ANMAT has been a member of the ICH council since 2019 in the category of observer member . Following compliance with all the necessary requirements, including the incorporation of ICH guidelines and maintaining active participation in the working groups, the membership has been changed to regulatory member.

Source: ANMAT

4 June
Anvisa changes the rule that deals with the post-registration changes to biological products

Collegiate Board Resolution (RDC) 876/2024 published on 3 June modifies the rule on post-registration changes and cancellation of biological products (RDC 413/202 0). 

  • The objective of the changes is to optimize the process of filing petitions necessary to update the registration of biological products, as well as their analysis by Anvisa.    
  • The change allows changes considered intrinsic (that is, when a main change leads to other inevitable or consequential changes and the same set of data is involved) to be exempt from protocols other than the main change or the set of related main changes . 

RDC 413/2020, when published, brought many new features in relation to the procedures and flows necessary for requesting and evaluating post -registration changes . 

  • To clarify doubts, the Agency published guidance documents . 
  • However , almost four years after its publication , there was a need for greater adjustments that could simplify and rationalize protocols on the part of companies.   
  • This is because changes to the registration of biological products are often complex and involve several modifications together, which led to the need for several protocols to regularize a change and this overload reflected a counterproductive scenario.  
  • Thus, to overcome the large number of protocols received since 2020 and which generated a significant queue for analysis of often joint petitions , Anvisa decided to change article 22 of RDC 413/2020 , dispensing with extra protocols. 

Source: Anvisa

27 May
Anvisa approves new regulation for registration of biosimilar medicines

Today, Anvisa approved the new regulation for the registration of biosimilar medicines .   

  • The objective of the new standard is to simplify the development process of these products, based on the safe relaxation of requirements.
  • The regulation will make it possible to waive some specific steps and studies when technically feasible, thus promoting a transparent and predictable regulatory environment for the sector. 
  • The points and requirements for proving comparability between products were exhaustively discussed during the regulatory process.
  • One of the novelties of the new regulation is the possibility of using a comparator reference medicine acquired in international territory in a situation of unavailability and if the necessary technical requirements have been proven. 
  • The regulation approved today reflects Anvisa’s recognition of the importance of patient access to biological products , as the use of biosimilars is an important public health strategy to reduce the costs of medicines and increase accessibility to biological products and new technologies . technologies, safely and effectively. 

Source: Anvisa

5 May
Anvisa will use analysis from equivalent foreign authorities for GMP inspection and the certification process

Anvisa published Normative Instruction (IN) 292/2024 , which establishes the optimized procedure for the purposes of analyzing Good Practices certification of Manufacturing and the criteria for defining Equivalent Foreign Regulatory Authorities (AREE) for the inspection process of medicines, biological products, cannabis products for medicinal purposes and active pharmaceutical ingredients (IFA). Regulatory trust – reliance – will bring more agility to the entire certification process.

  • The regulations define that authorities that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the International Council for Harmonization of Technical Requirements for Medicinal Products for Human Use (ICH) will be considered AREE. Currently, forty-two (42) authorities meet the AREE requirement for inspection purposes and are listed in Annex I of this IN.
  • The optimized analysis procedure aims to speed up the analysis of Certification requests filed with the Agency, without renouncing the technical rigor necessary to conclude compliance with the GMPs.

Three levels of regulatory confidence are defined in the regulations and were based on documents from the PICs reliance working group: 

  • Partial, when a complete analysis of the AREE inspection report or equivalent document is carried out to evaluate compliance with GMPs, which can be adopted unilaterally by Anvisa.
  • Full, when a simplified analysis of the ARRE inspection report is carried out to evaluate the service provided by PBFs, which can be adopted unilaterally by Anvisa.
  • Mutual Recognition, when, based on a regulatory trust program and signature of a mutual bilateral Agreement, Anvisa and AREE will accept the inspection report or GMP certificate from the counterparty.

The standard comes into force on 1 June 2024 and companies interested in adopting the optimized analysis procedure will be able, using a specific subject code, to use this analysis route.

2 May
Anvisa and Health Canada sign new Confidentiality Agreement

Anvisa signed a Confidentiality Agreement with the Regulatory Operations and Enforcement Branch of the Canadian Department of Health (Health Canada).

  • The new agreement aims to strengthen the exchange of technical information and inspection reports on good manufacturing practices for medicines, biological products, active pharmaceutical ingredients and medical devices.
  • Anvisa and Health Canada already had signed instruments in the areas of consumer safety and medicine and food regulation.
  • The signed instrument will allow progress in Anvisa’s bilateral relationship with the Canadian authority and will facilitate the establishment of possible regulatory trust mechanisms.

Source: Anvisa

30 April
Anvisa to draft Public Consultation for regulation on clinical trials for drug registration

Anvisa approved today, the opening of the Public Consultation (CP) to review Collegiate Board Resolution No. 9, of 2015. This Resolution deals with the Regulation for conducting clinical trials aimed at registering medicines in Brazil.

For the director reporting on the topic, Meiruze Freitas, “the guiding pillar for the review of RDC nº 9, of 2015, was to improve Anvisa’s regulatory performance in the approval and monitoring of clinical trials, based on health risk.

During the same meeting, the Regulatory Impact Analysis Report (AIR) was presented, which, after an in-depth analysis, confirmed the need to review current legislation, aiming to adapt it to innovative scenarios and ensure the harmonization of Brazilian regulations with international standards.

The Public Consultation (CP) marks a significant advance by proposing the adoption of reliance mechanisms as a strategy to improve processes and optimize the analyzes conducted by Anvisa.

The CP period will be 45 days, allowing an opportunity for all interested parties including the population in general to contribute their considerations and suggestions on the topic under discussion.

Source: Anvisa

9 April
Anvisa launches pioneering program to support startups for drug innovation

Anvisa launched Call Notice n. 1 dated April 5, 2024, which aims to support the development of new synthetic medicine and biological product of interest in health services.

  • This innovative initiative recognizes the need for new medicines and the importance of fostering innovation in the Brazilian healthcare ecosystem.
  • The notice is specifically aimed at Brazilian startups , strengthening the role of regulation in promoting innovation and development in health in the country.
  • The program is aligned with the guidelines of the National Strategy for the Development of the Health Economic-Industrial Complex and Anvisa’s Innovation Policy, and aims to accelerate market access to new medicines, meeting the urgent medical needs of the population.

Three startups will be chosen , each developing, respectively, a herbal medicine, a new synthetic medicine and a biological product, to participate in the regulatory evaluation pilot project. The primary objective is to support these companies in navigating health regulations, from the initial phases of product development.

The initiative seeks to offer specific regulatory support, aiming to facilitate compliance with health requirements and accelerate the process of innovation in medicines in the country. Additionally, the aim is to gather lessons that will contribute to improving Anvisa’s guidance and support strategies for innovations in the medicine sector. 

Source: Anvisa

14 June
PIC/s Guide to Good Manufacturing Practice (GMP): manufacturing principles for medicines and APIs

On 3 June 2024, the Determination of Manufacturing Principles at Australian manufacturing sites was updated so that PIC/S Guide to GMP (01 February 2022), PE009-16 (PIC/S Guide to GMP version 16) applies. For therapeutic goods other than blood, blood components and biologicals, this means compliance with this guide, including the Annexes, other than:

  • Annex 4 (Manufacture of veterinary medicinal products other than immunologicals)
  • Annex 5 (Manufacture of immunological veterinary medical products)
  • Annex 14 (Manufacture of medicinal products derived from human blood or plasma). 

This update:

The guide applies to the manufacture of all medicines and APIs unless exempt under provisions in the Act.

The transition period from 3 June 2024 to 2 September 2024 allows manufacturers to assess and plan for any changes needed to comply with Annex 16.

Further information is available at the link below.

Source: TGA

24 April
Nitrosamine impurities acceptable intakes update

The TGA has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent updated information from the European Medicines Agency The changes include minor editorial amendments, increases to the AI limit for a nitrosamine impurity and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines.

Sponsors and manufacturers are expected to be familiar with the current acceptable intakes (AI) for nitrosamine impurities in medicines that TGA consider acceptable. This is detailed on the TGA website.

13 June
Updated Guidelines on the Regulation of Therapeutic Products in New Zealand -Overview of regulation of therapeutic products

Edition 2.0 of May 2024 of the above guidelines has been published. This Guideline provides an overview of therapeutic product regulation in New Zealand.

Among the updates are the following:

  • Format and legislation references updated;
  • updated organisational information, mandatory standards for medical devices removed and replaced with website links, removal of categorisation tools and information duplicated on the Medsafe website.

You can view the updated guidelines here.

Source: Medsafe

4 June
Mean applicant screening response time

HSA’s target screening turn-around-time from the date of receipt of the application dossier to the date of acceptance or non-acceptance/withdrawal of the application (excluding applicant’s response time) is 50 working days (WD).

For new and major variation applications accepted in the period 01 Oct 2023 to 31 Mar 2024, the mean screening time taken by HSA was

  • 31.0 WD for NDA
  • 33.9 WD for GDA and
  • 20.7 WD for MAV applications respectively

On this page, you can view the  bi-annual updates of the mean applicant response time for new and major variation applications.

Source: HSA

31 May
Summary of Responses to Feedback from Public Consultation on the Proposed Amendments to Regulation 23 of the Health Products (Therapeutic Products) Regulations

The HSA invited stakeholders to provide feedback on the proposed amendments to regulation 23 of the Health Products (Therapeutic Products) Regulations 2016 (“Regulations”). The public consultation commenced on 1 March 2024 and closed on 12 April 2024.

  • A total of 36 responses were received to this consultation.
  • The consultation responses were positive and supported the proposed implementation of restraining patents and amendments to regulations 23 of the Regulations.
  • Most of the feedback relate to queries on the scope of patents, as well as the patent declaration process under the revised regulation 23.
  • HSA has published information detailing the scope of patents and the patent declaration process in Annex 1 (see link at the end of the post) to provide the necessary clarity.
  •  HSA also received suggestions on additional measures to the mechanism under the revised regulation 23.

Further information is available at the link below.

Source: HSA

24 May
HSA further Affirmed by World Health Organization for its medicines regulatory system

The HSA has received further recognition from the WHO in the area of market surveillance and control for its medicines regulatory system.

  • The latest achievement acknowledges that HSA’s WHO-Listed Authority (WLA) status now covers all regulatory functions for all medicines, from generics to new chemical entities, biotherapeutics and similar biotherapeutic products.
  • This affirms that HSA is recognised globally as operating at an advanced level of regulatory performance, ensuring that medicines in Singapore meet high safety, efficacy and quality standards. It also demonstrates that the Authority is committed to continuous improvement and excellence in regulatory oversight.
  • HSA was one of the first three regulatory authorities to be designated as WLA in 2023.

Source: HSA

4 June
Revision of CDSCO Guidance for Industry on pharmacovigilance requirements for Human vaccines

CDSCO has published Version 2.0 of the draft guidance with the title above. You can comment on it (with valid justification) until 13 June 2024 by emailing

Source: CDSCO

31 May
Revision of timelines for variation applications of registered products and a pilot study

To provide greater clarity and more effective monitoring, NPRA plan to revise the current timelines for variation applications outlined in the Malaysian Variation Guideline for Pharmaceutical Products (MVG) and Malaysian Variation Guideline for Biologics (MVGB)

  • Before finalising these new timelines, a pilot study with a duration of 1 year will be conducted, starting on June 1, 2024. Table 1 on this page displays the proposed new timelines. All PRHs to plan their submissions in accordance with these new timelines.
  • Please note that the NPRA will not reject variation applications that exceed the maximum number of permitted variation types per registered product as listed in Table 1. Instead, the timelines may be extended beyond the new timelines.

Source: NPRA

30 May
Update to Guidance Document For Preparation of GMP Inspections on TMHSC

The fourth edition (June 2024) of the guidance document has been published.

Effective 1st June 2024, the following documents need to be uploaded into the QUEST system during the application of initial / pre-licensing/ pre-approval GMP inspection:

  1. Latest Site Master File
  2. Layout Approval Letter
  3. Pre-inspection Checklist

Source: NPRA

21 May
Guideline on Electronic Labelling (E-Labelling) For Pharmaceutical Products in Malaysia

This guideline has been published. Its erves as a guide for the implementation of voluntary e-labelling.

  • E-labelling is defined as the provision of an approved product information that includes the package insert (PI) and/or Consumer Medication Information Leaflet (RiMUP) electronically via a machine readable Quick Response (QR) code on the outer carton/inner label of the product that links to the NPRA QUEST system.
  • When PI and/or RiMUP is distributed via e-labelling, physical printed copies may also be distributed with the product. It is the responsibility of the Product Registration Holder (PRH) to provide the physical printed copies when it is required.
  • The implementation of e-labelling is voluntary and applies to new drug products, biologics and generic products containing scheduled poisons for human use only.
  • Extension of e-labelling to other product categories will need to be further reviewed.

Source: NPRA

8 May
Revision of timelines for variation applications of registered products pharmaceutical products, a pilot study

The NPRA continuously works towards improving efficiency, not only for pre-marketing product assessments but also for post-approval changes.

To provide greater clarity and more effective monitoring, the NPRA to revise the current timelines for variation applications outlined in the Malaysian Variation Guideline for Pharmaceutical Products (MVG) and Malaysian Variation Guideline for Biologics (MVGB).

For information, NPRA is continuously working towards improved efficiency, not only for pre-marketing product assessments but also for post-approval changes. To provide greater clarity and more effective monitoring, we are in the plan to revise the current timelines for variation applications outlined in the Malaysian Variation Guideline for Pharmaceutical Products (MVG), Malaysian Variation Guideline for Biologics (MVGB), and Malaysian Variation Guideline for Natural and Health Supplement Products.

Before finalising these new timelines, a pilot study with a duration of 1 year will be conducted, starting on June 1, 2024.

Please view Table 1 on this page to better understand how to plan variations for this pilot.

  • All PRHs are advised to plan their submissions in accordance with these new timelines.
  • Please note that NPRA will not reject variation applications that exceed the maximum number of permitted variation types per registered product as listed in Table 1. Instead, the timelines may be extended beyond the new timelines.

Source: NPRA

29 May
SAHPRA Attains ISO 9001 Certification As Confirmation Of Its Robust Quality Management Processes

(SAHPRA) has attained its ISO 9001:2015 certification following a rigorous audit by the South African Bureau of Standards (SABS), a milestone that serves as a testament to the implementation of an effective and robust organisation-wide Quality Management System (QMS).  

A fully functioning QMS is core to achieving quality objectives that ensure that health products in South Africa meet statutory and regulatory standards of quality, safety, and efficacy.

Source: SAHPRA

28 April
SAHPRA And Botswana Medicines Regulatory Authority (BoMRA) sign MoU To Enhance Medicines Regulation In The Region

The South African Health Products Regulatory Authority (SAHPRA) and the Botswana Medicines Regulatory Authority (BoMRA) have signed a memorandum of understanding (MoU) that will see the two regulators partner on various areas to improve access to new medicines and therapies, the control of falsified and substandard medicines and the sharing of best practice and regulatory information, amongst others.

The MoU between SAHPRA and BoMRA will allow the regulators to develop a cooperative partnership towards ensuring access to safe, quality, and effective health products in the respective countries.

  • The partnership paves the way for the two regulators to collaborate and share information on the assessment of medicines and health products, which will result in efficiencies in the medicine approval processes in both South Africa and Botswana.
  • This agreement also enables information sharing on the post-marketing monitoring of medicines for adverse drug reactions, resulting in more robust safety and efficacy monitoring in the interest of the health of the citizens of both countries.
  • The MoU also formalises joint port of entry operations between SAHPRA and BoMRA aimed at protecting the citizens of both countries from the illegal importation of unregistered, falsified and substandard medicines and health products.

Source: SAHPRA

13 June
Guidance: Transparency for machine learning-enabled medical devices: guiding principles

In 2021, the U.S. FDA, Health Canada and the UK MHRA jointly identified 10 guiding principles for good machine learning practice (GMLP).

GMLP supports the development of safe, effective and high-quality artificial intelligence/machine learning technologies that can learn from real-world use and, in some cases, improve device performance.

The FDA, Health Canada and MHRA have further identified guiding principles for transparency for machine learning-enabled medical devices (MLMDs). These principles build upon the GMLP principles, especially:

  • principle 7: focus is placed on the performance of the human-AI team
  • principle 9: users are provided clear, essential information

You can read the guidance here.

In this document:

  • ‘transparency’ describes the degree to which appropriate information about an MLMD (including its intended use, development, performance and, when available, logic) is clearly communicated to relevant audiences
  • ‘logic’ refers to information about how an output or result was reached or the basis for a decision or action
  • ‘explainability’ refers to the degree to which this logic can be explained in a way that a person can understand

Logic and explainability are aspects of transparency.

Effective transparency:

  • ensures that information that could impact risks and patient outcomes is communicated
  • considers the information that the intended user or audience needs and the context it is used in
  • uses the best media, timing and strategies for successful communication
  • relies on a holistic understanding of users, environments and workflows

Source: MHRA

Guidance updated: Software and artificial intelligence (AI) as a medical device

This guidance has been updated to include reference to guiding principles on transparency for machine learning-enabled medical devices. You can view it here.

Source: MHRA

21 May
MHRA announces a proposed framework for international recognition of medical devices


  • has today published a statement of policy intent for international recognition of medical devices. It describes how the UK Government intends to recognise regulatory approvals from other countries (see CRCs below)depending on device type, class, and prior approval.
  • continues to review the list of comparable regulator countries and is in active discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan.
  • statement of policy intent focuses on ensuring safe access to quality-assured medical devices and reducing the duplication of assessments by comparable regulators to enable resource to be focused on more innovative products for the benefit of patient health.

The proposed framework is still in draft, and the final version would be integral with the future core regulations.

With reference to the intended policy on international recognition, the comparable regulator countries (CRCs) for the proposed framework will be:

CanadaHealth Canada
European UnionNational competent authorities in the member states of the EU/ European Economic Area (EEA)

On this page, you can see the eligibility criteria for the framework and the exclusions from international recognition.

Source: MHRA

MHRA announces consultation on improved safety for high risk in vitro diagnostic devices  

The MHRA has today launched a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices.

The new policy that the MHRA is consulting on would require manufacturers to comply with additional measures for certain high risk IVDs, such as blood tests used to identify blood type before transfusions or tests which identify life-threatening diseases, introducing harmonised requirements for these products.  

The agency is also seeking views on the removal of the Coronavirus Test Device Approval (CTDA) process to avoid duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements.   

The consultation is for the MHRA to seek views on the possible amendments to the Medical Devices Regulations 2002 to include Common Specification requirements for manufacturers of high-risk IVD devices.

This consultation builds upon public views after an initial consultation in November 2021 and will help inform further policy decision-making in this area. The scope of this consultation is specific to the Common Specification requirements for high-risk IVD devices. 

You can respond to the consultation online here.

The deadline to complete this consultation is Friday, 14th June 2024.

Source: MHRA

9 May
MHRA launches AI Airlock to address challenges in regulating medical devices that use Artificial Intelligence

The MHRA has launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).

Last month, the MHRA set out its strategic approach to AI in response to a white paper published in 2023 by Government.

  • This pilot project is a key part of that approach.
  • It will help the Agency to identify and address the challenges for regulating standalone AI medical devices (AIaMD), initially seeking out and supporting 4-6 virtual or real-world projects through simulation.
  • This will allow the Agency to test a range of regulatory issues for these devices when they are used for direct clinical purposes within the NHS.
The AI Airlock

The regulatory sandbox model is a recognised mechanism to help address novel regulatory challenges across sectors.

  • The AI Airlock is a world-leading version in healthcare, designed to assist in safe development and deployment of AIaMDs, and this project will follow that robust process so manufacturers can deliver what is required to ensure the real-world viability of these devices.
  • The MHRA’s regulatory AI Airlock takes into account evidence-based work produced by other bodies with a similar focus and the Agency will work collaboratively with the NHS AI Lab and the Department of Health and Social Care (DHSC).
  • AIaMD products are deployed via NHS infrastructure, making the Devolved Nations crucial to regulatory discussions around deployment and post-market surveillance.
  • The findings from this partnership between government, regulators and industry will inform future AI Airlock projects and influence future UK and international AIaMD guidance, including how we work with UK Approved Bodies on UKCA marking and with trusted regulatory partners on international recognition of medical devices.

You can read more about the AI Airlock here.

Source: MHRA

7 June
Proactive monitoring of highest-risk medical device clinical trials

As part of its commitment in the 2019 Action Plan for Medical Devices,the TGA is reviewing the safety information supporting notifications of the highest-risk implantable and cardiac invasive medical devices used in first-in-human clinical trials. Changes have been made in response to feedback from the consultation on proposed regulatory changes for clinical trials of medical devices.  They include:

Clinical Trials Notification (CTN) form enhancements 

The CTN form now includes new mandatory fields to:

  1. Better characterise the medical device in the clinical trial, for example:
    • risk classification
    • intended purpose
    • whether it’s an invasive or implantable medical device.
  2. Identify first-in-human trials and trials halted overseas for safety reasons. 

There is also a new attachment upload feature, which sponsors are encouraged to use to upload the Investigator’s Brochure (or another equivalent document) to minimise requests for further information. 

These changes came into effect on 5 April 2024

The updated CTN form will help the TGA to identify first-in-human trials for the following devices at high risk of immediate, catastrophic consequences if they fail to perform:

  • cardiac assist devices (artificial hearts, ventricular assist devices, intra-aortic balloon pumps, cardiomyoplasty devices)
  • heart valves and valve repair devices (surgical/percutaneous/mechanical valves, annuloplasty rings, valve repair clips)
  • pacemakers and leads
  • implantable cardiac defibrillators 
  • transcatheter cardiac occluder devices 
  • cardiac mapping and ablation catheter devices
  • implanted intracerebral/subcortical stimulator devices
  • aortic stent and aortic graft devices.

The TGA considers‘first-in-human’ to mean trials in which the investigational device has not been used in humans previously. 

Legislative changes

Legislative changes have been made to:

  1. Enable the TGA to require information about the safety of medical devices used in clinical trials. For example, information regarding materials, engineering and sterility.
  2. Enable inspection of medical device trials conducted under a CTN, and the documentation supporting them, to make sure they’re compliant with Good Clinical Practice.

The Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023, which included these changes, came into effect on 28 November 2023.

Further information is available at the link below.

Source: TGA

15 March
Companion diagnostics guidance update- public consultation

The TGA is seeking feedback on the updated draft Companion Diagnostics (CDx) Guidance document.

The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the requirements for companion testing, including:

  • A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion testing,
  • An introduction to the concept of the ‘companion testing plan’ to recognise the CDx component evaluations undertaken as part of the medicine application.
  • Improved clarity on clinical and analytical performance requirements for CDx, and
  • Case studies to assist sponsors of medicines and devices on the regulatory process and the technical documentation required for an IVD CDx.

You can respond to the consultation here.

Source: TGA

Consultation start date: 15 March 2024

Consultation end date: 17 June 2024

5 June
HPRA Medical Devices Newsletter – Issue 58 – June 2024 published

The newsletter is packed with information provided under the following headings:

  • 2024 Regulatory Milestones
  • EU Regulatory Updates
  • HPRA focus for 2024
  • HPRA Updates for Health Institutions – In-House in vitro Diagnostic Medical Devices
  • Economic operator registration obligations
  • HPRA distributor and importer inspections 2024
  • Clinical investigations update
  • Published documents

There is information in the newsletter that applies to anyone in the EU working on Medical Devices.

Source: HPRA

24 May
Guide for Health Institutions which Manufacture and Use In-house in vitro Diagnostic Medical Devices in Ireland

The first guide for Health Institutions which Manufacture and Use In-house in vitro Diagnostic Medical Devices in Ireland has been published.

The purpose of this guide is to provide an overview of legislation and key concepts relevant to in-house IVDs. This guide is targeted towards health institutions in Ireland that manufacture and use in-house IVDs. The requirements of the IVDR are described here, including details on when they apply, taking into account national legislation for IVDs (S.I. No. 256 of 2022 and S.I. No 365 of 2022).

Source: HPRA

17 May
Guide to applications for a variation to a manufacturer’s authorisation

HPRA has published a new guide for the above. You can download it here.

Source: HPRA

16 May
Guide to Clinical Investigations Carried Out in Ireland

This guide has been updated. There are changes throughout the document. Here, you can view the track changed (18 Nov 2022) and clean (16 May 2024) versions of the document. The guide:

  • provides an overview of the legislation on clinical investigations (CIs) involving medical devices.
  • also provides guidance on how to submit applications to carry out CIs in Ireland to the Health Products Regulatory Authority (HPRA).
  • is primarily targeted towards CI sponsors (e.g. manufacturers, academic groups, clinical research organisations), who wish to carry out CIs involving medical devices in Ireland. The information may also be useful for ethics committees and other stakeholders.

Source: HPRA

30 May
Pamphlet published – Develop your innovative medical product in Japan and Bring it to the world

In order to achieve realization of innovative drugs, medical devices, and regenerative medical products, PMDA launched the Regulatory Science Consultations, mainly for universities, research institutions, and venture companies that possess promising “seed-stage” researches or technologies.

During the consultations, advice will be provided on the tests needed in the early product development stage and the necessary clinical trials.

To support this initiative, the PMDA has published a comprehensive 52 page pamphlet entitled Develop your innovative medical product in Japan and Bring it to the world. The pamphlet concerns both of the following types of consultations:

  • Regulatory Science General Consultation
  • Regulatory Science Strategy Consultation(Pre-consultation meeting+ Consultation)

Source: PMDA

23 May 2024
Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)

Revision 4 (May 2024) of the above document has been published. The document has been updated substantially, inclding the following new Q&As:

  • 1.3 How to obtain advice on the qualification/classification of my drug-device combination, especially for borderline products?
  • 2.4. Can I provide a notified body opinion concluding on partial compliance with the GSPR? What is the scope of the notified body opinion ?
  • 2.7. How should I submit minor changes to the terms of the Marketing Authorisation for integral DDC following changes to the device (or device part)?
  • 2.8. Will I need to provide a new/updated notified body opinion for changes related to the medicinal product (e.g. extension of indication, new strength, new pharmaceutical form) in an integral drug-device combination?
  • 3.2.1 If co-packaged medical devices class I and class IIa, are supplied without an individual packaging and it is not technically feasible to implement the labelling requirements on the device itself, what alternative solutions could be considered to display the labelling requirements?

Here, you can view the track changed (Nov 2023) and clean (May 2024) versions of the document. The blog post entitled The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products has been updated in line with Revision 4 (May 2024).

Source: EMA

22 May
Revised Q&A for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746) published

Revised Q&A (Rev 4 May 2024) has now been published. Here, you can view the track changed (Nov 2023) and clean (May 2024) versions of the document.

The document will guide marketing authorisation holders, applicants and notified bodies through some of the changes introduced by the medical devices and in-vitro diagnostics regulations. It includes the following:

  • insights on integral drug-device combinations and their lifecycle management
  • labelling requirements for medical devices co-packaged with medicinal products
  • information on the consultation procedures for medical devices with ancillary medicinal substances and companion diagnostics

Further information is available in this blog post.

Source: EMA

2 April 2024
Scientific Advice Pilot for high risk medical devices

EMA is running a pilot that enables the expert panels to provide scientific advice for manufacturers of high-risk medical devices.

EMA invites EU-based manufacturers or their authorised representatives to apply for a third phase of the pilot by 30 June 2024. They can use the following application form:  

For the third pilot phase, applicants can indicate if they would be willing to have an HTA body observe their project. In such cases, EMA will inform them whether this will be possible.

Source: EMA

27 May
Cofepris approves software for cardiac monitoring in smart watches

Cofepris authorized the second software for use as a medical device, which will benefit thousands of patients diagnosed with atrial fibrillation (AF) by alerting about any irregularity in heart rhythm.

  • This software , used in a smartwatch, is aimed at people aged twenty-two and older, diagnosed with AF, a condition that includes an irregular and commonly fast heartbeat. When detected early, it can be treated effectively.
  • With this tool, patients will receive real-time information about their heart rate, allowing irregular episodes in heart rhythm to be identified. Additionally, the software facilitates ongoing monitoring and recognizes trends in estimated AF burden.
  • They will also be able to access data about their lifestyle to understand the impact of their habits on that condition.
  • It should be noted that this software is intended for self-care; However, it does not replace conventional methods of diagnosing, treating, or monitoring AF. If irregularities in the heart rhythm are detected, it is recommended to notify specialist medical personnel.
  • Cofepris issued this authorization under the equivalence agreement with the US FDA after an evaluation carried out by the specialized ruling team of this health authority, in accordance with the Guide for obtaining the health registration of medical devices .

Source: Cofepris

20 May
Cofepris authorizes first high-tech software for the treatment of myocardial infarction

Cofepris has authorized its first high-tech software that improves the precision and prognosis of the most common treatment for myocardial infarction, marking a milestone in therapeutic innovation in Mexico in favor of the health of millions of patients.

This is the first software that the health authority has authorized as a medical device, which uses an interactive screen that receives, processes and transmits aortic and distal blood pressure signals, providing medical personnel with the ability to personalize treatments and significantly improving patient outcomes.

This authorization was issued based on the equivalence agreement with the US FDA and after the evaluation carried out by Cofepris’ specialized judging team, in accordance with the Guide for obtaining the health registration of medical devices .

Source: Cofepris

17 May
Study supporting the monitoring of availability of medical devices on the EU market – 8th notified bodies survey on certifications and applications (MDR/IVDR)

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) – through the European Health and Digital Executive Agency (HaDEA) – has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”.

  • The study started in December 2022 and will be running for 36 months (December 2025). The study has been contracted to a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Areté and Civic Consulting.
  • In the context of the study, a dashboard has been developed. The dashboard presents an overview of the data gathered from different stakeholders. In addition, comparable data from previous surveys of notified bodies conducted by the European Commission have been integrated in the dashboard.
  • You can view the latest update on the study here.

Source: European Commission

9 May
FDA final rule will include IVDs manufactured by laboratories under FD&C act

The FDA is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory.

  • In conjunction with this amendment, the FDA is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs.
  • This phaseout policy:
    • includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs
    • is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.

This rule becomes effective on 5 July 2024.

8 April
Anvisa will use assessments from foreign regulatory authorities to register medical devices

Anvisa published, in the Official Gazette of the Union this Monday (8/4), Normative Instruction (IN) 290/2024 , which establishes the optimized procedure for the purposes of analyzing and deciding petitions for registration of medical devices.  

With this measure, the Agency now has more agility in the evaluation process of products already approved by equivalent foreign regulatory authorities , consolidating a major step in the adoption of regulatory trust mechanisms.  

The text of the IN stipulates that, as of 3 June 2024, medical devices authorised for markets regulated by four equivalent foreign regulatory authorities (Australia, Canada, the USA and Japan) may have their assessments shortened, based on the requesting companies.

To this end, documents must be presented demonstrating that products intended for the Brazilian market have the same production characteristics, indications and intended use approved by the recognized regulatory authority. 

Source: Anvisa

30 May
ICH M14 Guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b

EMA has published a document with the above title for consultation.

The use of pharmacoepidemiological studies as a source of evidence for regulatory decision-making has increased globally, and multiple guidelines and best practice documents have been developed by health authorities and professional societies. Generation of robust evidence to be used for regulatory purposes relies on the quality of the data and the application of sound pharmacoepidemiological methods. 

This guideline provides internationally harmonised guidance and outlines recommendations and high-level best practices for the conduct and analysis of non-interventional pharmacoepidemiological studies using fit-for-purpose data for the assessment of the safety of medicines (drugs, vaccines, and other biological products). It aims to streamline the development and regulatory assessment of study protocols and reports, and improve their ability to be accepted across health authorities.

You can read more about the ICH process in this blog post.

Consultation start date: 30 May 2024

Consultation end date: 30 August 2024

Source: EMA

2 May
Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling

The concept paper proposes to revise the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling (EMEA/CHMP/203927/2005)

Comments should be provided using this EUSurvey form.

Start of public consultation: 2 May 2024

End of public consultation: 31 August 2024

12 April
Draft Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

This guideline is the 2nd revision of the CHMP Guideline formerly called “Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents”. It addresses the requirements for demonstration of therapeutic equivalence (TE) between orally inhaled products containing the same active moiety(ies).

Comments should be provided using this EUSurvey form.

Start of public consultation: 12 April 2024

End of public consultation: 30 October 2024

Source: EMA

Draft HMA/EMA guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application (MAA) dossier

This guidance document is intended to be applicable to information/documents pertaining to the initial and variation of marketing authorisation application (MAA) dossiers of medicinal products for human use for which the regulatory procedure has been finalised, under the national, mutual recognition, decentralised and centralised procedures.

“Finalised” shall mean that the marketing authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

Comments should be provided using this EUSurvey form.

Start of public consultation: 12 April 2024

End of public consultation: 28 June 2024

Source: EMA

Draft Guideline on the pharmaceutical quality of inhalation and nasal medicinal products

This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal 5 products (EMEA/CHMP/QWP/49313/2005 Corr).

The main aim of the first revision is to consolidate the information available in the previous guidance documents, the related published questions and answers, also taking into consideration recent advancements in the field, common practice and new regulations, including the medical device regulation.

Comments should be provided using this EUSurvey form.

Start of public consultation: 12 April 2024

End of public consultation: 31 October 2024

Source: EMA

25 March
Draft Guideline on quality, non-clinical and clinical requirements 4 for investigational advanced therapy medicinal products in clinical trials

The guideline provides guidance on the structure and data requirements for a clinical trial application fo investigational ATMPs. The guideline is multidisciplinary and addresses development, manufacturing and quality control as well as non-clinical and clinical development of ATMPs.

You can view the draft here.

Start of second public consultation: 25 March 2024

End of second public consultation: 31 May 2024

Source: EMA

22 February
ICH E2D(R1) Guideline on post-approval safety data Step 2b – Revision 1

The above revision is currently under public consultation. You can view the consultation document here.

Consultation start date: 22 February 2024

Consultation end date: 22 June 2024

You can read more about the ICH process in this post.

Source: EMA
29 May
Draft Regulation on Promotional Activities of Medicinal Products for Human Use and Foods for Special Medical Purposes

In order to determine the rules to be followed in the promotional activities of human medicinal products and foods for special medicinal purposes, an amendment was made to the Regulation on Promotional Activities of Human Medicinal Products published in the Official Gazette No. 29405 dated 03/07/2015 and “Promotion of Human Medicinal Products and Foods for Special Medical Purposes”.

  • A draft “Regulation on Promotional Activities” has been published.
  • The draft Regulation in question and the necessary information on the subject can also be accessed at

You can view the Draft regulation and the comment form at the link below.

Consultation start date: 28 May 2024

Consultation end date: 10 June 2024

Source: TITCK

24 May
Release of draft (Step 2) ICH Guideline E2D(R1) : Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

Health Canada is consulting on the above draft.

The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management practices.

This revised guideline is proposed to clarify the management of post-approval safety information from new or increasingly used data sources including the need to adapt definitions and standards. In addition, the revised guideline provides recommendations that are harmonised to the extent possible given differences in post-market safety reporting requirements among ICH regions.

Please use the ICH template for public consultations to send in your comments. Comments provided to Health Canada should be submitted by the date listed in the table above in order to allow sufficient time for their assessment and subsequent transmission to the ICH.

You can read more on the ICH steps in this blog post.

Consultation start date: 24 May 2024

Consultation end date: 22 August 2024

Source: Health Canada

21 May
Draft for Comments || Rules and Regulations on the Issuance of Authorization for Registration Applications of Pharmaceutical Products and Active Pharmaceutical Ingredients for Human Use by the Food and Drug Administration

The key changes in the draft include the following:

1. Adoption of terminology harmonized with other FDA issuances being developed (specifically pharmaceutical product and active pharmaceutical ingredient).

2. Updated provisions under definition of terms, general conditions, and types of applications covering the identical pharmaceutical product applications (IPPA) to be established.

3. General provisions allowing bundling of applications for post-approval changes (specific conditions and requirements to be covered by implementing guidelines through FDA Circular).

You can view the draft here and the Annexes at the link below.

All comments may be sent via email to using the comment form. The deadline for submission of comments is 30 May 2024.

Source: FDA

4 March
Public consultation on ICH Guideline E2D(R1) launched in Switzerland

Swissmedic has launched the public consultation on Guideline E2D(R1) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines)

  • Stakeholders in Switzerland have until 22 June 2024 to comment on the draft of Guideline E2D(R1) “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports”.
  • Since the original ICH E2D guideline was agreed in 2003, new sources of post-approval safety information have emerged or are applied more frequently (e.g. social media, market research programmes, patient support and assistance programmes) which vary in terms of their characteristics and their contribution to the quality of post-approval safety information.
  • The definitions and regulatory guidance in ICH E2D are no longer sufficient to provide guidance on current practices and needs.
  • Therefore, the original considerations and standards need to be carefully revisited in order to adapt the existing concepts, principles and definitions of the ICH E2D guideline and to support appropriate safety surveillance and actions in consideration of the new sources of safety information.

Links to the guideline and feedback form can be found on this page.

Consultation start date: 4 March 2024

Consultation end date: 22 June 2024

Source: Swissmedic

21 May

Today, the Council of Ministers approved the EU AI Act following approval by the European Parliament in March 2024. The Council’s vote paves the way for the formal signing of the legislation and its subsequent entry into the Official Journal of the EU (OJEU).

The EU AI Act will come into force 20 days after its publication in the OJEU, though most of its provisions will not take effect for a further two years after that date.


13 March
European Parliament formally adopts the EU AI Act

The European Parliament has formally adopted the EU AI Act in a move that brings the proposed legislation to the brink of becoming EU law. This the world’s first ever law on AI.

MEPs voted overwhelming in favour of adopting the regulation on Wednesday – 523 MEPs voted in favour, 46 voted against, and there were 49 abstentions.

Under the EU AI Act, a new risk-based system of regulation applicable to AI will apply across EU member states.

Under the new framework, some uses of AI will be prohibited entirely, while the strictest regulatory requirements are reserved for ‘high-risk’ AI systems and the providers and deployers of such systems.

The EU AI Act was proposed by the European Commission in April 2021. Those proposals were subsequently scrutinised by the European Parliament and Council of Ministers, the EU’s other law-making institution. A compromise text was developed and has now been formally adopted by MEPs, but for the text to become EU law, the Council must also adopt the EU AI Act


29 May
ICH M14 draft Guideline reaches Step 2 of the ICH process

On 21 May, the ICH M14 draft Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines” reached Step 2 of the ICH process.

  • The M14 draft Guideline is available for download on the M14 Page.
  • This draft Guideline outlines recommendations and high-level best practices for the conduct of these studies, to streamline the development and regulatory assessment of study protocols and reports.
  • These recommendations and practices also seek to improve the ability of the study protocol and/or results to be accepted across health authorities and support decision-making in response to study results.

You can read more about the ICH process in this blog post.

Source: ICH

ICH adopts M12 guideline on drug interaction studies

On 21 May, the ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process i.e. the Guideline was adopted.

  • This Guideline provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product.
  • The supporting Q&A is intended to provide additional clarification and improve harmonisation of drug interaction assessment.
  • Further information can be found on the M12 page, including the Guideline and the Step 4 Introductory Training Presentation available for download.

Source: ICH

17 May
Publication with the involvement of Swissmedic, on the risk assessment of nitrosamine impurities

A scientific article on the development and application of the “Carcinogenic Potency Categorisation Approach” (CPCA) has been published.

  • With the involvement of experts from Swissmedic, an international working group of representatives of regulatory authorities compiled data and principles that led to the development of a model for the risk assessment of nitrosamines based on chemical structural characteristics. This was published in a scientific journal.
  • The open-access scientific publication:
    • describes the principles of the Carcinogenic Potency Categorisation Approach (CPCA) published at the end of 2023. The method makes it possible to standardise the definition of acceptable intakes (AI) for medicinal products, including complex chemical nitrosamine impurities, specifically nitrosamine drug substance-related impurities” (NDSRI). This speeds up safety assessments of nitrosamine impurities.
    • also uses sample molecules to illustrate how the CPCA is used to determine acceptable intakes for nitrosamine impurities. This allows industry and manufacturing experts in particular to understand the classification into different risk classes.

Source: Swissmedic

3 May
WHO releases two draft appendices to draft guideline on good manufacturing practices (GMPs) for excipients released in 2023

The WHO has released two draft appendices to a draft guideline on good manufacturing practices (GMPs) for excipients released in 2023. Links to both appendices are provided below.

WHO GMP for excipients used in pharmaceutical products – Appendix 3 1: Risk Management in the 4 production and control of excipients used in pharmaceutical products

WHO GMP for excipients used in 3 pharmaceutical products – Appendix 4 2: List of examples of high-risk excipients

Please submit your comments through the online platform, PleaseReview™.Comments should be submitted through the online platform by 9 June 2024.

WHO aims to collect feedback and publish a working document for discussion and possible adoption by its Expert Committee on Specifications for Pharmaceutical Preparations in August or September 2024.

Sources: WHO, RAPS

18 April
Swissmedic receives grant from the Bill & Melinda Gates Foundation

On 27 March 2024, Swissmedic signed a new grant agreement with the Bill & Melinda Gates Foundation,  to continue supporting regulatory authorities in low and middle-income countries for a further three years.

  • The agreement between Swissmedic and the Bill & Melinda Gates Foundation is based on the Memorandum of Understanding (MoU) signed in January 2014 by the Foundation, the Federal Department of Home Affairs (FDHA) and the Federal Department of Foreign Affairs (FDFA) with the aim of strengthening the regulatory systems in low and middle-income countries, thereby improving and accelerating access to healthcare and medicines. Its focus is on countries in sub-Saharan Africa.
  • The overall aim of the project is to bring high-quality, life-saving medicines to patients as quickly as possible.
  • Swissmedic signed its first grant agreement with the Foundation in December 2015. Since then, Swissmedic, the three parties to the MoU and the World Health Organization (WHO) have developed a support programme consisting of three main areas of engagement:
    • Harmonisation: Support for the implementation of the African Medicines Regulatory Harmonization (AMRH) programme at regional and continental level and towards the operationalisation of the African Medicines Agency (AMA)
    • Access: Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP)
    • Capacity building: Swissmedic training opportunities for regulatory authorities in low and middle-income countries

Comment: It is interesting to note that the amount of the grant is not mentioned anywhere and where there are any strings attached to such a grant.

Source: Swissmedic