International regulatory news in brief

Image with the word 'Regulations'

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). Each tab includes the date for most recent update under that particular tab. Click on the respective tab to view the news for that region/topic.

UK
23 April 2025
MHRA reminder to industry about ‘UK Only’ statement on medicines

If you work in pharmaceuticals or a related industry, you’ll be aware that there are new arrangements for human medicines under the Windsor Framework that came into effect on 1 January 2025.

  • This is a reminder to industry that the ‘UK Only’ statement can only be applied to medicines via a sticker until 30 June 2025.
  • After this date, ‘UK Only’ must be printed directly onto packaging.
  • If you are using stickering now, it is important to ensure you are ready for ‘UK Only’ to be printed on packs from 1 July 2025.
  • Stickers will not be accepted for products released to market from that date, however, products with ‘UK Only’ stickering that have been QP certified before 1 July 2025, can continue to be supplied to patients until the date of their expiry.
  • Parallel Import (PLPI) products are not affected and can continue using stickers over labelling.
  • For further information on applying the ‘UK Only’ statement and using stickering, please see the MHRA guidance on labelling and packaging of medicinal products for human use following agreement of the Windsor Framework, including the stickering section of our Q&A document.
  • You can also email the MHRA at patient.information@mhra.gov.uk with more general questions about labelling requirements.
  • Visit the MHRA Windsor Framework Hub for guidance and supporting materials

Source: MHRA on LinkedIn

16 April 2025
Guidance – Risk minimisation measures for medicines

The MHRA has published guidance on risk minimisation measures.

Risk minimisation measures are put in place to facilitate the safe and effective use of medicines by healthcare professionals, patients and their carers or guardians.

  • The purpose of additional risk minimisation measures is to reduce or prevent the risk of an adverse event, or to reduce the severity or impact on the patient should an adverse event occur.
  • They can:
    • be used to support discussion between a patient and their healthcare professional(s), to ensure an informed decision is made regarding a particular treatment.
    • also be used to support treatment monitoring, prevent medication error and ensure appropriate administration of a medicine.

The guidance is provided under the following headings:

  • Purpose of risk minimisation measures
  • Decision on risk minimisation measures
  • Examples of risk minimisation measures
  • Controlled access programmes

Source: MHRA

8 April 2025
Guidance updated -MHRA phase I accreditation scheme

Added updated versions of the following have been published:

  • phase I accreditation scheme requirements –
  • guidance on the phase I accreditation scheme
  • list of accredited phase I units

The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, in particular for those conducting first in human (FIH) trials.

The scheme aims to make sure trials are as safe as possible and to create public confidence in the regulation of phase I clinical trials.

Source: MHRA

3 April 2025
National assessment procedure for medicines

The MHRA has published new guidance on the MHRA’s national assessment procedure for marketing authorisation applications as well as Guidance on Submission and assessment timetables for innovative medicines applications.

  • This new guidance for applicants is effective for applications received after the publication date.
  • The national assessment procedure guidance applies to national MA applications for both innovative and established medicines, but the requirements, procedures and timetables differ. Both innovative and established medicine applications are defined in the guidance.
  • Timetables are measured in calendar days excluding regulatory clock-stops.  

Source: MHRA

1 April 2025
Guidance updated: Established medicines: MAA application changes

Fees section updated to include new fees for 2025.

More information about established medicines in this post.

Source: MHRA

31 March 2025
New UK-wide Innovative Licensing and Access Pathway (ILAP)

As of today, the New ILAP is open for Innovation Passport applications. Products that meet all the eligibility criteria and which best meet the selection criteria will be awarded an Innovation Passport to enter the ILAP.

The ILAP is a unique initiative which aims to accelerate the time to patient care for transformative new medicines and drug-device combinations, facilitating patient access by providing a single integrated platform for sustained collaborative working between the developer, the MHRA, the UK Health Technology Assessment (HTA) bodies and the National Health Service (NHS), as well as patients.

You can read more about the New ILAP in this blog post.

28 March 2025
Guidance updated – Blue Guide: advertising and promotion of medicines

Appendix 4 Best practice guidance on the sale of medicines for pain relief has been updated. You can view it here.

Source: MHRA

26 March 2025
Decentralised manufacture hub

Statutory Instrument 2025 87 will introduce regulatory changes for the manufacture of medicines at – or close to – the point of patient care.  

  • Point of care (POC) and modular manufacture (MM) are collectively called decentralised manufacture (DM). 
  • DM processes allow medicinal products to be made at or close to a patient’s location for administration of the medicine.  
  • To enable DM, the UK has amended the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004 through Statutory Instrument 2025 87. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 will come into effect on 23 July 2025. 

Further information is available in this blog post.

Source: MHRA

MHRA launches new monthly safety bulletin and redesigned safety alerts

The MHRA has launched a new monthly safety bulletin, the ‘MHRA Safety Roundup’, the latest step in a three-year Strategy for Improving Safety Communications to make medicines and medical device information clearer and more accessible for healthcare professionals.

  • The bulletin, which will be sent to subscribers and published online at the end of each month, provides a summary of all the MHRA safety alerts for the past month including
    • drug safety updates (DSU)
    • device safety information (DSI)
    • national patient safety alerts
    • recalls and medicines notifications, and letters sent to healthcare professionals.
  • It also contains an MHRA news section highlighting key safety information about medicines, medical devices and healthcare products that may be of interest to readers.

Source: MHRA

20 March 2025
Guidance updated – Supplying authorised medicines to Northern Ireland

This guidance has been updated with information confirming that medicines moved from Great Britain to Northern Ireland must be declared for customs or moved using the Windsor Framework simplified processes.

Source: MHRA

13 March 2025
Guidance updated – GCP for clinical trials

In this guidance, the GCP inspection dossier clinical trial spreadsheet has been updated.

Source: MHRA

6 March 2025
Consultation outcome – MHRA consultation on statutory fees – proposals on ongoing cost recovery

The MHRA held a public consultation on proposed amendments to its statutory fees. The consultation ran between 29 August 2024 and 24 October 2024 .

This document summarises the responses to the consultation and outlines the MHRA response to feedback and proposed next steps.

  • The majority of respondents did not agree with the proposal for a new medical devices registration fee. The decision has been taken to proceed with the wider fees uplift and continue exploring options on this fee. The implementation date for the proposed changes is early Q1 2025/26.
  • Further guidance on the proposed changes will be published on the fees page in due course and will be informed by the feedback given.
  • Given the necessary steps to implement the changes, it is likely that the updated medicines fees will be implemented slightly before the fees for medical devices and blood products for transfusion.

Source: MHRA

28 February 2025
Guidance updated – Format and content of applications for agreement or modification of a Paediatric Investigation Plan

This guidance provides detailed information on: 

  • the required format and content of applications for agreement on or modification of a paediatric investigation plan (PIP) 
  • requests for waiver and deferrals 
  • the operation of the compliance check in accordance with the Human Medicines Regulations 2012 (HMRs). 

It has been updated with respect to the Windsor Framework and clarity of instructions.

Source: MHRA

19 February 2025
Guidance updated- Exceptions and modifications to the EU guidance on good pharmacovigilance practices (GVPs) that apply to UK MAHs and the MHRA

GVP are a set of measures drawn up to facilitate the performance of pharmacovigilance in the EU.

This guidance describes the aspects of the EU guidance on GVP that no longer apply to the MHRA and UK MAHs, or are to be read subject to modification.

Significant changes have been made to the guidance. They can be viewed clicking the link  ‘See all updates’ on this page.

Source: MHRA

12 February 2025
Guidance updated- Importing investigational medicinal products into Great Britain from approved countries

This guidance has been updated to to take account of the EU implementation of the Clinical Trials Regulation No 536/2014 related to EU QP certification.

Source: MHRA

10 February 2025
MHRA Real-World Evidence Scientific Dialogue Programme

The MHRA’s Data Strategy sets out an ambition to promote data-driven innovation and early access to innovative products through Real-World Evidence (RWE) and proactive approaches to safety surveillance.

  • In support of this, the MHRA is launching a pilot RWE Scientific Dialogue Programme during 2025.
  • This initiative is designed to help innovators refine their evidence generation strategies while providing clear guidance on regulatory expectations.
  • The programme aims to facilitate robust decision-making across the entire lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations relevant to the UK.
  • The pilot phase of the RWE Scientific Dialogue Programme will be run during 2025.
  • The aims of the Real-World Evidence Scientific Dialogue Programme are:
    • To clearly set out the MHRA’s expectations for RWE methodologies for evidence generation through consolidation and harmonisation of core principles, and to produce specific use cases
    • To enable commercially sensitive discussions between applicants and the MHRA, with a specific strategic focus on RWE.
    • To increase clarity of regulatory and HTA expectations for data, analytical methodologies, and endpoints used to generate RWE.
    • To generate shared learning which can be disseminated to the broader ecosystem through reflection papers developed collaboratively between MHRA, NICE, and industry stakeholders.
  • An Expression of Interest for the MHRA Real-World Evidence Scientific Dialogue Programme pilot formis available here.
  • Expressions of interest will be accepted from 10 February 2025 until 11.59pm BST 4 April 2025.
  • The MHRA will review submissions and notify applicants of the outcome in the first week of May 2025.

Further detailed information is available at the link below.

Source: MHRA

7 February 2025
Guidance updated – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA

This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)

It has been updated to add latest version of Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority.

Source: MHRA

6 February 2025
Guidance updated – Clinical trials for medicines: manage your authorisation, report safety issues

Updates have been made to to the section on development safety update reports(DSURs) including a new user reference guide. No further specifics have been provided.

Source: MHRA

5 February 2025
Decision tree for navigating nanotechnology-based products for medical application

The MHRA has received an increase in interest and scientific advice queries on nanomedicines in recent years, particularly on lipid nanoparticles.

  • There appears to be a perception that there is no clear regulatory pathway available for these products and researchers are unclear how to develop their products in accordance with the various guidelines currently in place. 
  • The decision tree is to help support researchers and developers to understand how different ICH guidelines and European regulatory agencies can be applied to support the development of nanomedicines, although they are not meant to be exhaustive.
  • The classification, new active substances or ‘nanosimilar’ pathways are highlighted in the flow diagram as well. 
  • This may help support development of medicinal products involving ‘nano’ drug delivery systems liposomes and lipid nanoparticles (LNPs).
  • It should be noted, however, that the nanomedicine decision tree is not considered as a substitute for a regulatory or scientific advice meeting with the MHRA when specific issues may also need to be considered for your medicinal product or medical devices. 
  • Consideration for medical devices is also outside the scope of this decision tree.

Source: MHRA

Switzerland
1 April 2025
Addendum 11.7 of the European Pharmacopoeia in force

The Institute Council has put Addendum 11.7 of the European Pharmacopoeia into effect on 1 April 2025.

Further information is available at the link below.

Source: Swissmedic

Expansion of the Swissmedic position paper on Real World Evidence

Swissmedic has updated its position paper on the use of Real World Evidence (RWE).

  • The document now includes an appendix with an overview of relevant international guidelines and publications reflecting the current state of science and technology.
  • This appendix serves as additional guidance for the scientific and regulatory assessment of RWE in the approval process.
  • The updated position paper is valid from 1 April 2025.

Source: Swissmedic

Adaptation of the guidelines for company meetings for approval procedures

To ensure that questions from companies relating to the development and approval of medicinal products can be clarified efficiently and purposefully in dialogue with Swissmedic, it has optimised the possibilities for company meetings.

  • Companies can now request a pre-submission meeting with Swissmedic at any stage of a drug development project.
  • This newly designed meeting allows companies to engage in early communication with Swissmedic and is intended to help clarify content and procedural issues they have with Swissmedic.
  • The new pre-submission meeting combines the following existing meeting types :
    • “Scientific Advice Meeting,”
    • “Pipeline Meeting,” and
    • “Presubmission Meeting”
  • A mutual exchange of scientific information is also possible within the pre-submission meeting.
  • The pre-application meeting is not tied to a specific future application for approval and applies to all procedures. A combination of meeting topics is possible.
  • Swissmedic has revised the Guidelines  on Company Meetings for Authorization Procedures accordingly and made further editorial adjustments.
  • The Guidelines on  Company Meetings for Authorization Procedures and the new meeting before application submission takes effect on April 1, 2025.

Source: Swissmedic

Roundtable eSubmissions

Swissmedic and the pharmaceutical industry regularly exchange ideas on topics related to the submission of electronic applications for medicinal products within the framework of the eSubmissions Roundtable.

  • The eSubmissions Roundtable provides a platform for the participating parties to exchange information and experiences and, in particular, serves the coordinated and practice-oriented further development of processes and systems in this area.
  • The eSubmissions Roundtable evolved from the former eCTD Roundtable. The name change to ‘Roundtable eSubmissions’, effective April 1, 2025, reflects the expanded focus of the Roundtable.
  • The roundtable consists of representatives from the pharmaceutical industry, representatives from the Operational Support Services department, and optionally specialists from Swissmedic’s specialist departments and IT organization.
  • Over the years, direct exchange between Swissmedic and the pharmaceutical industry has proven effective in promoting mutual understanding of the parties’ concerns and efficiently developing and implementing procedural and technical changes.
  • The roundtable is attended by a maximum of 12 representatives from the pharmaceutical industry who, due to their daily work and experience, are familiar with the technology and processes of application submission.

Further information is available at the link below.

Source: Swissmedic

7 March 2025
Overview of international drug approvals – International cooperation in approval procedures

In addition to the standard approval procedures, Swissmedic also carries out or participates in international approval procedures so that patients in Switzerland and partner countries have faster access to medicines.

Collaboration with other national regulatory authorities allows Swissmedic to strengthen its international collaboration, to share knowledge and expertise across jurisdictions and to promote regulatory convergence. Depending on the procedure, applications are simultaneously or subsequently submitted to Swissmedic and collaborating authorities, and are assessed across multiple countries.

The short brochure “Collaborative Assessments Procedures” contains a brief overview of the individual procedures for international drug approvals and provides information on special requirements.

It includes information on e.g. The Access Consortium and Project Orbis.

Source: Swissmedic

1 March 2025
Adaptation of the Guideline PSUR PBRER Information Submission HAM

The PSUR PBRER Information Submission HAM guideline has been fundamentally revised editorially. The aim is to explain the applicable formal and regulatory aspects more clearly to the marketing authorisation holder and thus facilitate correct submission. Some chapters have been newly added or clarified for better understanding.

The adapted guideline PSUR PBRER Information Submission HAM is valid from 1 March 2025.

31 January 2025
Revised Interpretation of the Mutual Recognition Agreement (MRA) between Switzerland and Canada

The Canada-Switzerland MRA on Medicinal Products: Drug GMP Compliance Certification, Sectoral Annex on GMP has been in force since 2000.

  • As of January 31, 2025, Health Canada and Swissmedic have agreed to expand the existing approach of recognizing GMP inspection results to include inspections conducted in countries outside the respective parties’ territories and of stable medicinal products derived from human blood or human plasma.
  • In addition, Health Canada and Swissmedic have agreed to introduce processes for information exchange and reliance on product-specific on-site evaluations (OSE) by Health Canada and pre-approval inspections by Swissmedic.

The text of the MRA has not yet been revised as this interpretation was possible on the basis of the existing MRA. However, Swissmedic and Health Canada confirm their intention to revise the MRA in due course and to adapt it to developments over the past 25 years .

Source: Swissmedic

Turkey
4 March 2025
Overseas manufacturing facilities inspected by TITCK in 2024

TITCK has published a list of overseas manufacturing facilities inspected in 2024. YOu can view it here.

Matters concerning GMP inspection applications for products that are manufactured abroad and imported to Turkey are performed within the framework of the provisions of the “Guide on Applications for GMP Inspections of Overseas Production Facilities”.

Source: TITCK

Germany
16 April 2025
Publication of the Joint Announcement by the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines (PEI) on the Notification of Variations for Purely National Marketing Authorisations in Accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013

This Joint Announcement of BfArM and PEI replaces the second Announcement on the notification of variations for purely national licences in accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 which are within the BfArM’s responsibility in accordance with Section 77 dated 15 June 2016 and considers the amendments to the Variation Regulation (Regulation (EC) No. 1234/2008) following the entry into force of Commission Delegated Regulation (EU) 2024/1701.

Source: BfARM

1 March 2025
New validation criteria for eCTD submissions – mandatory from 1st March 2025

As of 1st March 2025 new validation criteria for eCTD submissions are mandatory.

The transition period was from December 2024 till the end of February 2025.

As of 1st March 2025 it is mandatory to submit all electronic submissions in the eCTD format using the new validation criteria of version 8.0.

For further information please check the following EMA website:
https://esubmission.ema.europa.eu/ectd/

Source: BfARM

European Commission
16 April 2025
Health Technology Assessment: First joint clinical assessments begin

The first two joint clinical assessments for medicinal products have started under the Health Technology Assessment Regulation (EU 2021/2282).

  • The first is for a paediatric cancer treatment and the second is for an advanced therapy medicinal product to treat skin cancer.
  • The joint clinical assessments are undertaken by assessors and co-assessors from competent organisations in EU Member States, as well as in Norway, Iceland and Lichtenstein.
  • The medicinal product for the treatment of paediatric low-grade glioma will be assessed by the National Centre for Pharmacoeconomics, Ireland, and the Institute for Quality and Efficiency in Health Care, Germany.
  • The advanced therapy medicinal product for the treatment of melanoma will be assessed by the National Authority for Health, France, and the Agency for Health Technology Assessment and Tariff System, Poland.
  • The joint clinical assessments are conducted in parallel with the marketing authorisation process, which is undertaken by the European Medicines Agency.
  • For health technology assessments, the appointed assessors and co-assessors will produce draft joint clinical assessment reports and summary reports, which must be endorsed by the Member State Coordination Group on Health Technology Assessment (HTA), no later than 30 days following the adoption of a Commission decision granting a marketing authorisation for the medicinal product.
  • The joint clinical assessment reports produced for medicinal products and medical devices will be considered by Member States in their health technology assessment at national level, thus facilitating access pathways for patients to innovative health technologies.

Further information is available on Health Technology assessment in this blog post.

Source: European Commission

11 March 2025
Proposal for a Critical Medicines Act

On 11 March the European Commission proposed the Critical Medicines Act to improve the availability, supply and production of critical medicines within the EU.

The CMA also aims to:

  • increase access to other medicines of common interest, such as those for rare diseases, and
  • to address the fact that some medicines are not available in certain markets.

The key features of the CMA are:

  • Strategic Projects for critical medicines or their ingredients can be designated, so that they benefit from easier access to funding and fast-tracked procedures.
  • Public procurement to incentivise the resilience of supply chains of critical medicines or to improve access to other medicines of common interest.
  • Collaborative procurement among different member states will be supported by the Commission at the request of member states, to address availability and access disparities of critical medicines and other medicines of common interest.
  • International partnerships with likeminded countries/regions will be explored, to broaden the supply chain and reduce dependencies on single suppliers.
  • State aid guidelines to assist member states in financially supporting such strategic projects.

Source: European Commission

30 January 2025
European Commission launches Biotech and Biomanufacturing Hub

The European Commission launched a Biotech and Biomanufacturing Hub. 

From start-up to scaling up, this page is your EU biotech and biomanufacturing hub that provides tools and resources to help you succeed in the biotech and biomanufacturing sector:

  • Check what you need to do to bring a biotech or biomanufacturing solution to market: Learn about the essential regulations and requirements to bring your biotech ideas to life.
  • Find research infrastructures for your biotech or biomanufacturing R&D: Access cutting-edge facilities and data-sharing platforms to advance your research.
  • Scale up your biotech or biomanufacturing business: Connect with networks, funding, market insights, pilot and testing facilities to grow your company.

Source: EU Commission

European Medicines Agency
17 March 2025
Reflection paper on use of real-world data in noninterventional studies to generate real-world evidence for regulatory purposes

The final reflection paper outlining key principles for conducting and assessing non-interventional studies using RWD has been published.

  • These studies can complement data from clinical trials and fill in knowledge gaps. However, understanding the limitations and overcoming them is key to ensuring reliable evidence.
  • The paper covers legal obligations and regulatory requirements, study design, bias, confounding and effect modification, governance and transparency, data quality and statistical analyses.
  • Its part of the newly published roadmap for regulatory guidance on RWE.

Source: EMA

25 February 2025
New clinical trial map launched in the EU

A new clinical trial map is now accessible from the public website of the Clinical Trials Information System (CTIS).

  • The map is designed to provide patients and healthcare professionals with easy access to comprehensive, real-time information about clinical trials conducted in their area, increasing access to clinical research in the European Union (EU).
  • Building on the public information contained in CTIS, the map improves how people use the system and find information about clinical trials.
  • Users can look for ongoing trials by geographic area and medical condition.
  • The search supports queries in lay language and includes an autocorrect system that provides suggestions in case of misspellings.
  • Search results offer investigator’s contact details, enabling members of the public to directly enquire about potential enrolment into a given trial.
  • The first version of the map is provided in English. Additional EU languages will be added in future releases.

Source: EMA

Ireland
24 February 2025
Updated Guide for National Scientific and Regulatory Advice

This guide has been substantially updated. Here, you can view the track changed (20 Sep 2023) and clean (24 Feb 2025) versions of the guide.

Source: HPRA

18 February 2025
Certificate of free sale process updates

HPRA has recently updated its process for applying for certificates of free sale for medical devices. These changes include:

  • One application form to be used for all certificate of free sale requests.
  • New Excel device schedule, where the applicant should list all devices to be included on the certificate.
  • Updated the information to be included on certificates of free sale template.
  • New dedicated email address for application form submissions and queries relating to certificates of free sale, devicecerts@hpra.ie.

Full details on the updates can be found on our certificates of free sale webpage.

Source: HPRA

USA
9 April 2025

Today, the U.S. FDA is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods.

  • The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices.
  • The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data).
  • Implementation of the regimen will begin immediately for investigational new drug (IND) applications, where inclusion of NAMs data is encouraged, and is outlined in a roadmap also being released today.
  • To make determinations of efficacy, the agency will also begin use pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.

Source: FDA

14 March 2025
CDER Nitrosamine Impurity Acceptable Intake Limits

Updates have been made to the following Tables:

  • Table 1: FDA Recommended AI Limits for Certain Hypothetical NDSRIs and Other Identified Nitrosamine Impurities
  • Table 3: Recommended Interim AI Limits* for Certain Nitrosamine Impurities** for Approved or Currently Marketed Products

The revision table at the end of the page shows all the revisions. Whilst Table 2 shows as having been updated on 31 Dec 2024, the table at the end of the page does not show any updates in Table 2.

Source: FDA

Canada
11 February 2025
What we heard: Draft guidance on expanded access clinical trials

Health Canada developed the Draft Guidance on Expanded Access Clinical Trials to facilitate access to drugs that have not yet been authorized or are not available in Canada.

These include drugs for certain patients with serious or life-threatening conditions where authorized alternatives may be limited (for example, oncology, rare diseases, some mental health disorders and pediatric medicine).

The Draft guidance on expanded access clinical trials was published on August 2, 2024, and opened to the public for consultation until October 31, 2024.

This “what we heard” report:

  • provides background and context for the draft guidance
  • summarizes the consultation approach and
  • gives an overview of the comments received by Health Canada

Source: Health Canada

14 January 2025
Publication of revisions to the Guidance Document – Patented Medicines (Notice of Compliance) Regulations: Notice

Health Canada is pleased to announce an update to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations.

The Guidance Document has been amended to align with existing Health Products and Food Branch policies and the Office of Patented Medicines and Liaison’s current practices as they relate to the administration of the Patented Medicines (Notice of Compliance) Regulations.

Brazil
24 April 2025
Pre-Qualification Inspections (IPQs) for manufacturers of synthetic medicines

Anvisa has confirmed that Pre-Qualification Inspections (IPQs) for manufacturers of synthetic medicines will begin soon.

  • The IPQ is an optimized assessment tool, based on risk criteria, provided for in the Collegiate Board Resolution (RDC) 823/2023.
  • Its objective is to assess whether a given company is able to consistently comply with the requirements for registration and post-registration of medicines. 
  • Prequalification can be applied to synthetic medicines and processes still in the development phase, or to petitions related to these medicines awaiting analysis by Anvisa.
  • Thus, aiming at transparency in the regulatory process to be initiated, POP-F-ANVISA-221 is now available, with detailed instructions on IPQs, as well as the forms related to it. 
  • In addition to enabling agility in the analysis of registration processes and post-registration petitions, the establishment of IPQs aims to stimulate the technical development of pharmaceutical industries. 

Source: Anvisa

28 March 2025
Anvisa provides guidance on filing petitions in CTD format

The validity of RDC No. 947/2024 requires adaptations to the way petitions are currently carried out.

  • Anvisa, as a regulatory member of the ICH has undertaken to implement several of the Council’s guidelines, including the use of the Common Technical Document (CTD) format and organization for submitting applications for registration and post-registration of medicines and biological products.
  • These guidelines were internalized in the form of Guide No. 24, dated 14 August2019, and involve the manual protocol of an electronic media (pen-drive) containing the entire dossier in CTD format.
  • The manual protocol alternative, however, became an exception with the publication of RDC No. 947, dated 12 December 2024, which deals with the procedures for filing documents with the Agency, generating doubts among companies about how to proceed with sending the media.
  • In summary, the changes are:
    • Registration subject codes and post-registration changes are no longer received manually, but are only received in electronic format (including for dossiers in CTD format);
    • Amendment subject codes – CTD format are no longer received electronically containing only a declaration, and are now received in manual format, containing all documentation in CTD format (electronic media);
    • The subject codes for amendments – CTD format, which were previously filed once in the process, are now filed in all petitions for registrations and post-registration changes in the CTD format for medicines and biological products.

Source: Anvisa

Anvisa publishes new guide for biological products and radiopharmaceuticals

Two new guidance documents for the registration of biological products and the notification of radiopharmaceuticals have been published on the AnvisaLegis Portal .

  • The first of these corresponds to the Agency’s internalization of Guideline Q5A(R1), “Evaluation of the viral safety of biotechnological products derived from cell lines of human or animal origin”, approved within the scope of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). 
  • The document is an update of the first publication in 1999 and aims to reflect the new types of biotechnology products available and the advances in manufacturing technology and analytical methods for validating virus elimination since then. As a member of the ICH Council, Anvisa is committed to internalizing these guidelines, after carrying out a process of external consultation and deliberation by the responsible bodies. 
  • The second, Guide for Submitting Requests for Notification of Radiopharmaceuticals Exempt from Registration, is a publication that aims to provide guidance on the regularization of radiopharmaceuticals through notification. 

Source: Anvisa

10 March 2025
You can now subscribe to Avisalegis

Anvisa’s legislation portal now   has a new service called “  Avisalegis ”.

  • The service allows any interested party to receive messages when there are regulatory publications from the Agency.
  • To register for “  Avisalegis ”, simply register an email and select the publications of interest.
  • It is possible to choose, for example, one or more types of acts (e.g. Public Consultation and Resolution of the Board of Directors) or macro-themes of interest among Anvisa’s areas of activity (e.g. Food and Medicines).
  • When registering, it is possible to combine several publications of interest and thus create different rules for receiving notifications by email.
  • If you do not wish to receive messages, you can choose to consult the publications in the tool itself, where lists are presented by date.

Source: Anvisa

26 February 2025
Anvisa publishes manuals with guidelines on the new clinical research standard (RDC 945/2024)

Anvisa has published several manuals with guidelines for companies on the instruction of the Drug Clinical Development Dossier (DDCM) and Specific Clinical Trial Dossier (DEEC) processes, and on the Notification of Adverse Events (AEs) and the Safety Monitoring of Clinical Trials, based on the Collegiate Board Resolution (RDC) 945/2024 and 
Normative Instruction (IN) 338/2024 .

  • The manuals are non-binding regulatory instruments, adopted in addition to health regulations, for educational and guidance purposes, and are not intended to expand or restrict established technical or administrative requirements.
  • The Submission Manual for the Clinical Development Dossier of Medication (DDCM) and Specific Dossier for Clinical Trials (DEEC) aims to guide professionals in the field with information on how to instruct DDCM and DEEC processes in light of RDC 945/2024, IN 338/2024, IN 345/2025 and other regulatory acts.
  • The Manual for Reporting Suspected Serious and Unexpected Adverse Reactions (SUSARs) and Safety Monitoring in Clinical Trials aims to guide the sponsor and delegated Clinical Research Representative Organizations (CRPOs) on how to perform safety monitoring and report SUSARs (suspected unexpected serious adverse reactions) to Anvisa. In addition, its objective is to guide the investigator on how to perform safety monitoring in order to minimize risks to clinical trial participants.
  • The VigiMed Empresa User Manual aims to guide the appropriate use of this system for reporting SUSARs. Additionally, the Registration/Registration Change Form – VigiMed and the Clinical Trial Submission Form (Faec), version 6, are being made available.

Source: Anvisa

11 February 2025
Check out the latest update to the list of Brazilian Common Names

Anvisa published, in the Official Gazette of the Union this Monday (10/2), 
Normative Instruction 343/2025 , which updates the list of Brazilian Common Names (DCBs). Eight new names were included and one was changed.

You can view the update here.

Source: Anvisa

31 January 2025
Companies must submit a report on the marketing of medicines

The Executive Secretariat of the Chamber for the Regulation of the Medicines Market (SCMED) has confirmed that the Medicines Market Monitoring System (Sammed) will be available starting next week, to send the marketing report for the second half of 2024.

  • Submissions can be made between 00:01 on Monday (3/2) and 23:59 on March 14, 2025.
  • Reports sent after the defined deadline will not be accepted.
  • The report must be sent via Sammed .
  • Guidelines for filling out and sending the report are available in the 
    Marketing Report manual.  
  • Only by sending the report will companies be able to adjust prices in 2025.
  • It is worth noting that only companies that have submitted the appropriate marketing report to the Chamber for the Regulation of the Medicines Market (CMED), in accordance with CMED Notice No. 11, dated August 12, 2015, will be entitled to the maximum adjustment in drug prices in 2025.  

Source: Anvisa

27 January 2025
Anvisa publishes Advanced Therapy Product Monitoring (ATMP) Reports

Anvisa has published the  Periodic Monitoring Reports for Registration of Advanced Therapy Products. 

  • The documents:
    • analyze all advanced therapy products registered with Anvisa since 2020, considering the data available after more than a year of approval.
    • were prepared in partnership with the companies holding the registration, within the scope of the project “Monitoring and Periodic Analysis of Advanced Therapy Products: Reassessment of the Benefit-Risk Profile and Social Transparency”.
  • The project, which began in 2024, had the support of all companies holding registrations for Advanced Therapy Products (PTAs) in Brazil.
  • The initiative reinforces the sector’s commitment to monitoring the safety and effectiveness of these innovative medicines.

Source: Anvisa

Australia
28 April 2025
More medicines to begin transition to sole ingredient names soon following end of dual labelling period.

Some medicine labels show both the old and new active ingredient name.

  • The TGA call this dual labelling.
  • Using both old and new names on labels gave consumers and health professionals time to adjust to new names.
  • The dual labelling period for most ingredient names ended on 30 April 2023.
  • After this date, labels can show the new ingredient name or show both names for up to 3 years before changing.
  • For some ingredient names, the dual labelling period continued until 30 April 2025.
  • Soon these medicines will start to show only the new name for ingredients.
  • Read more about Dual labelled medicine ingredient names start the transition to sole names.

Source: TGA

4 April 2025
GMP Clearance compliance verification pathway: progress update

The backlog of GMP Clearance CV applications is reducing having peaked in mid-October 2024 with a total number of 2547 CV applications in the TGA lodgement queue.

  • Since that time, the TGA has seen a ~10% reduction in the total number of applications (237 applications).
  • This is predominantly driven by a ~23% reduction in Non-Sterile Active Pharmaceutical Ingredients (API) stream (255 applications) and a ~10% reduction in Sterile Finished Product applications (25 applications).
  • The TGA anticipates that the overall application numbers will continue to reduce in the coming months as new GMP evaluators progress with training.
  • Focus will move to the Non-Sterile Finished Product stream to begin to reduce the number of these application types.

TGA will continue to provide updates on progress via the Sponsor Information Dashboard and through the TGA-Industry Working Group on GMP.

Source: TGA

3 April 2025
Updates to the Prescribing Medicines in Pregnancy database – March 2025

The Prescription Medicines in Pregnancy database has now been updated to include the new entries as shown at the link below.

Source: TGA

19 February 2025
Nitrosamine and Nitroso-structure impurities acceptable intakes update

TGA has published updated information for nitrosamine impurities and other nitroso-structure impurities in medicines consistent with recent EMA updated information.

  • The changes include additional clarification for sponsors and manufacturers of the TGA’s expectations, minor editorial amendments, increases to the Acceptable Intake (AI) limit for some impurities and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities and other nitroso-structure impurities in medicines.
  • The AI changes are tabulated on the updates to nitrosamines and other nitroso-structures page.

Source: TGA

12 February 2025

When new safety information for medicines is identified, the TGA works with the sponsors to update Product Information (PI) to ensure that health professionals and consumers have access to this information.

New safety information can be identified through the TGA’s ongoing safety monitoring activities or uncovered and submitted by sponsors themselves.

Some medicines have recently had safety related updates to their PI.

Source: TGA

19 February 2025
Nitrosamine and Nitroso-structure impurities acceptable intakes update

TGA has published updated information for nitrosamine impurities and other nitroso-structure impurities in medicines consistent with recent EMA updated information.

  • The changes include additional clarification for sponsors and manufacturers of the TGA’s expectations, minor editorial amendments, increases to the Acceptable Intake (AI) limit for some impurities and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities and other nitroso-structure impurities in medicines.
  • The AI changes are tabulated on the updates to nitrosamines and other nitroso-structures page.

Source: TGA

12 February 2025

When new safety information for medicines is identified, the TGA works with the sponsors to update Product Information (PI) to ensure that health professionals and consumers have access to this information.

New safety information can be identified through the TGA’s ongoing safety monitoring activities or uncovered and submitted by sponsors themselves.

Some medicines have recently had safety related updates to their PI.

Source: TGA

New Zealand
12 March 2025
Clinical trials – Protocol clarification letter

To provide guidance on reporting clinical trial amendments. The GRTPNZ for clinical trials (section 6.6.1) states that any changes to the trial protocol must be submitted and approved before they can be implemented. This statement is to further clarify this requirement and is effective immediately.

  • Clinical trial protocol clarification letters, and notes to file do not need to be approved by Medsafe before being implemented. 
  • They can be submitted for notification only and you will receive an acknowledgement of receipt.
  • Changes to clinical trial protocols should continue to be submitted and require approval prior to implementation.
  • Evidence of acceptance of protocol amendments by overseas regulators may also be submitted if they are available to assist Medsafe’s evaluation.

Source: Medsafe

Pakistan
21 April 2025
DRAP-PSW Gateway: Online application for Pharmaceutical export certificates

Effective immediately, the DRAP-PSW gateway will serve as the exclusive platform for the submission and processing of applications for the following certificates:

  • Export No Objection Certificate (NOC)
  • Certificate of a Pharmaceutical Product (CoPP)
  • Free Sale Certificate (FSC)
  • Good Manufacturing Certificates (GMP)

Source: DRAP

Advisory to therapeutic good manufacturers: Measures to prevent DEG/EG contamination in oral liquid preparations

DRAP is issuing this advisory due to global concern regarding oral liquid preparations contaminated with diethylene glycol(DEG) and ethylene glycol (EG) which has caused severe health issues, particularly in children as highlighted by the WHO.

Source: DRAP

Malaysia
10 April 2025
Directive on improving the application process for product registration for export purposes only/For Export Only (FEO) for pharmaceutical products, health supplements and natural products

This directive from the NPRA outlines improvements to the application process for registering pharmaceutical products, health supplements, and natural products intended solely for export (FEO).

  • Issued under the Drug and Cosmetics Control Regulations 1984, it details that only locally manufactured products with strong justification are eligible for FEO registration.
  • The directive simplifies documentation requirements and significantly reduces the registration timeframe to 40 working days.
  • Furthermore, it specifies distinct labeling requirements for FEO products’ Certificates of Pharmaceutical Product (CPP), clearly stating they haven’t been evaluated by the NPRA unless a concurrent application for local market registration is underway.
  • Finally, the directive addresses procedures for foreign products imported only for packaging and subsequent re-export.

Source: NPRA

2 April 2025
Submission of RiMUP for Evaluation by the Pharmacovigilance Section, PKKK

As of April 2025, all RiMUP for evaluation by the Pharmacovigilance Section (previously requiring manual submission) should be submitted through the QUEST 3+ system.

Please note: There is no change to the existing procedure for all products registered after 1 January 2014, whereby the RiMUPs are evaluated by the Centre of Product and Cosmetic Evaluation (PPPK).

Refer to the updated guidelines for specific details on the products involved [Garis Panduan Pelaksanaan RiMUP – Section 2: Table ].

Variation label:

Only RiMUPs for evaluation by the Pharmacovigilance Section should be submitted using the following new variation labels:

  • MiV-PA3(PV): For pharmaceutical or biologic products
  • MiV-PA2(PV): For natural products with therapeutic claims, and health supplements with disease risk reduction claims

Once a RiMUP has been submitted for evaluation by the Pharmacovigilance Section,  send an email to inform the team at [ rimup@npra.gov.my ]

Source: NPRA

14 March 2025
Directive Regarding the Expansion of the Scope of First-In-Human (FIH) Clinical Trial Products for Applications for Clinical Trial Import License (CTIL) and Authorization to Manufacture Unregistered Products for Clinical Trial Purposes (CTX) to Cell and Gene Therapy Products (CGTP)

This document from the NPRA announces a new directive, Bilangan 4 Tahun 2025, effective April 1, 2025.

  • The directive expands the scope of First-In-Human (FIH) clinical trial product reviews to include Cell and Gene Therapy Products (CGTP) for both import license (CTIL) and unregistered manufacturing (CTX) applications.
  • Previously, FIH applications were accepted in phases for new chemical entities, COVID-19 vaccines from local R&D, and biologics (excluding CGTP).
  • This latest instruction signifies NPRA’s readiness to assess the safety of complex CGTPs based on acquired experience, requiring adherence from all relevant parties.

Source: NPRA

Japan
31 March 2025

The PMDA has recently published the following three guidances:

Points to consider for:

Source: PMDA

26 March 2025
Checklist When Submitting Applications for New Active Ingredient Containing Pharmaceuticals (Chemical Products)

PMDA has published a document titled Checklist for Common Inquiry Cases to Be Noted When Submitting Approval Applications for New Active Ingredient Containing Pharmaceuticals (Chemical Products) (Early Consideration).

  • This checklist has been developed based on frequently raised queires during the quality assessment process for new drug applications conducted by the Office of New Drug I -V.
  • It serves as a reference for applicants to voluntarily verify the contents of their application forms by summarizing key points to note, along with their reasons and supplementary explanations.
  • Please note that it is not necessary to include all items listed in this checklist. Applicants may refer to it as appropriate, considering the characteristics and circumstances of each product.
  • The use of this checklist is expected to facilitate a more efficient submission and assessment processes for licence applications.

Source: PMDA

Examples of Documents on Assessment and Control of DNA Reactive (Mutagenic) Impurities attached to Clinical Trial Notification (Early Consideration)

The PMDA has published a document titled Example of Documents on Assessment and Control of DNA Reactive (Mutagenic) Impurities attached to Clinical Trial Notification (Early Consideration)

  • This document provides typical examples of how to prepare materials related to the evaluation and control approach of mutagenic impurities attached to clinical trial notifications.
  • It does not attempt to introduce new regulations or explain how to evaluate and control mutagenic impurities.
  • If the information submitted is sufficient, it is possible to submit documents prepared in different styles or formats.
  • Since the appropriateness of the control approach of mutagenic impurities is determined according to the status of individual products, and additional data may be required during the process of notification assessment, the utilization of consultation by PMDA should be considered if there is any uncertainty regarding the control approach of mutagenic impurities or the content of risk assessment.
  • This document was prepared taking into account the standard description at the stage of the clinical trial notification and it does not guarantee the acceptability of the control approach, etc. in the marketing authorization application.

Source: PMDA

21 March 2025
PMDA Washington D.C. Office

PMDA Washington D.C. Office has been established in Washington, D.C. as the first PMDA’s U.S. office since 1 November 2024.

  • In the office, PMDA will promote enhancement of regulatory cooperation and information exchange on regulations with administrative organizations in the U.S., including the U.S FDA on site.
  • For start-up located in the U.S., PMDA will provide information on Japanese regulations on reviews and post-marketing safety measures, as well as offer services including early general development consultation and related services.
  • PMDA believes that these measures will support to promote the development of innovative drugs and medical devices in Japan.

Source: PMDA

14 March 2025
New Drug Review with Electronic Data

This guidance has been updated under sub section Data Standards Catalog and Study Data Validation Rules.

Source: PMDA

22 January 2025
Check List for 30-day-Clinical Trial Notification Review on an Initial Clinical Trial Notification (Oncology Drugs)

PMDA has published a document with the above title. You can view it here.

Source: PMDA

14 January 2025
Questions and Answers (Q&A) on the Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars

A Q & A the Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars has been published.

Source: PMDA

7 March 2025
Guidelines for the Implementation of Drug Information Leaflets for Consumers (RiMUP)

This guideline has been updated in several sections including the following:

ii) Section 3.2.2 – Evaluation by the Pharmacovigilance Section, Quality Control & Compliance Center (PKKK) – method of submitting the first version of RiMUP for products to be evaluated by PKKK (effective 1 April 2025).
iii) Added the Malaysian Variation Guideline as one of the reference documents.
iv) Appendix – placed separately (documents for Appendix are uploaded on the NPRA website).

The submission checklist has also been updated and can be obtained at the link below.

NPRA

21 January 2025
Guidelines for the Implementation of Drug Information Leaflets for Consumers (RiMUP)

The following updated templates were published today:

Source: NPRA

Directives for the use of the Drug Registration Guidance Document (DRGD) Third Edition, Ninth Revision January 2025

This document, Directive Number 1 of 2025, from the Malaysian Ministry of Health, concerns the Drug Registration Guidance Document (DRGD).

  • It is the third edition, ninth revision, released January 2025.
  • The directive mandates that all drug product registration holders and relevant personnel follow this updated guidance.
  • The document itself provides detailed instructions on the registration process.
  • Finally, the directive’s effective date is 31 January 2025.
  • The DRGD Third Edition, Ninth Revision January 2025, can be accessed through the official website of the National Pharmaceutical Regulatory Agency (NPRA).

Source: NPRA

India
4 March 2025
Launching of registration of Clinical Research Organisation (CRO) applications through SUGAM portal

The Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th
September 2024, wherein registration of Clinical Research Organisation (CRO) has
been made mandatory with effective from 1st day of April, 2025.

You can view the notice here.

Source: CDSCO

30 December
Submission of applications for clinical trial site addition and change of principal investigator.

In order to streamline regulatory submissions, the above applications can now be submitted via the online SUGAM portal. Further inforation is available in this notice.

Source: CDSCO

Singapore
3 February 2025
HSA to launch “SHARE” for CTGTP Dealer’s Licensing and Certification

On 10 February 2025, HSA will launch of SHARE (Singapore Health Product Access and Regulatory E-System) for Cell, Tissue and Gene Therapy Products (CTGTP) Dealer’s Licensing and Certification.

From 10 February 2025, log in to SHARE with your Corppass for the e-services below:

  • Apply/Amend/Cancel CTGTP Dealer’s Licence 
  • Apply CTGTP Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) Certificates
  • Track/Withdraw Applications
  • Check Active CTGTP Dealer’s Licences and Certificates

Please refer to the HSA FAQ, which include steps to set up your SHARE login.

Source: HSA

Taiwan
6 January 2025
TFDA has launched the issuance of digital GMP certificates, providing convenient digital services.

To ensure the safety and quality of medicinal products, Taiwan has fully implemented the international PIC/S GMP standards and pharmaceutical manufacturers can apply for GMP certificates from the TFDA after inspection if found to be in compliance with PIC/S GMP.

  • Beginning July 31, 2024 besides issuing hard copies of GMP certificates, the TFDA also began issuing digital GMP certificates, which include a digital signature.
  • These digital certificates are encrypted using a digital signature that meets the global Adobe Approved Trust List and Taiwan’s Electronic Sig-natures Act, can quickly verify via scanning QR code or uploading PDF file to a verification platform.
  • More than a thousand times verifications have been conducted since the platform was launched

Source: TFDA

South Africa
4 February 2025
Landmark agreement among Africa’s leading National Medicines Regulatory Authorities to foster collaboration

The Africa CDC and AUDA-NEPAD are proud to announce the signing of a Memorandum of Understanding (MoU) among Africa’s WHO Maturity Level 3 National Regulatory Authorities (NRAs).

  • The MoU was signed by the the following regulatory agencies:
    • Ghana’s Food and Drugs Authority (FDA),
    • the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria,
    • Rwanda Food and Drugs Authority (FDA),
    • the Senegalese Pharmaceutical Regulatory Agency (ARP),
    • South African Health Products Regulatory Authority (SAHPRA),
    • Tanzania Medicines & Medical Devices Authority (TMDA), and
    • Medicines Control Authority of Zimbabwe (MCAZ).
  • The agreement marks a significant milestone in strengthening regulatory systems across the continent by fostering collaboration and reliance on regulatory decisions among signatory agencies while also creating an enabling environment for the local production of medical products.
  • It aims to create a framework that streamlines regulatory decisions to speed up the approval of medicines, vaccines and medical devices, while promoting collaboration on vaccine lot releases
  • Through this agreement, the signatories commit to streamline application submission and evaluation processes to expedite regulatory processes, reduce costs, and ensure timely regulatory decision-making.
  • This will be achieved through information sharing, work-sharing and reliance (either partially or fully) on the assessment reports generated by the participating authorities.
  • The MoU also establishes mechanisms to ensure that authorised products and clinical trials meet internationally accepted regulatory standards.
  • These agencies have established robust systems to ensure the safety, efficacy and quality of medical products in line with international regulatory standards.

Source: SAHPRA

Spain
22 April 2025
AEMPS publishes guide for the marketing of medical devices in Spain

AEMPS has developed a guide for the marketing of medical devices in Spain.

  • This document is aimed at manufacturers, importers, authorized representatives, and distributors who intend to market medical devices in Spain.
  • The guide includes information on the requirements that products must meet and the obligations of economic operators to market medical devices in Spain, helping them understand and comply with the requirements established in Regulation (EU) 2017/745  and Royal Decree 192/2023 of March 21, regulating medical devices .
  • In addition, the AEMPS has added new content and reorganized its website on medical devices.
  • This update includes the guide for the marketing of medical devices, as well as new information on specific products, such as Annex XVI products for non-medical purposes, and a specific section with the requirements and obligations that medical devices and economic operators must meet to be marketed in Spain.

Source: AEMPS

31 March 2025
AEMPS details the procedure for publishing clinical research reports on medical devices in Spain

Below is a summary of the procedure.

In Spain, the sponsor must submit the clinical research report and its summary 
within one year of the completion of the research, or within three months in the case of early termination or temporary suspension, through the  
General Registry of the General State Administration.

  • AEMPS will:
    • then label the documents and publish them with all relevant information including the date of the report, title of the research, name and contact details of the sponsor, unique identification number (CIV-ID), code or number of the clinical research plan and status.
    • also transmit the two labeled documents to the European Commission without undue delay after receiving them from the sponsor, indicating the date of receipt. This applies only to clinical investigations conducted under Articles 62 and 74(1) of the MDR.
  • The European Commission will verify that there are no duplicates, update the tracking file and upload the documents to the CIRCABC public directory one year after their submission to the competent authorities, where they will be stored in a dedicated CIRCABC public directory called MDR Clinical Research Reports and their Summaries.

Source: AEMPS

IMDRF
16 April 2025
Good machine learning practice for medical device development: Guiding principles

In January this year, the IMDRF published a document with the above title.

  • The ten guiding principles for Good Machine Learning Practice (GMLP) presented in this document are a call to action to international standards organizations, international regulators, and other collaborative bodies to further advance GMLP.
  • Areas of collaboration include research, creating educational tools and resources, international harmonization, and consensus standards, to inform regulatory policies and regulatory guidelines.
  • These guiding principles may be used to adopt practices from other sectors, tailor them to the medical technology and healthcare, and to develop novel practices for this domain.

You can read more about this guidance in this post by Jamie Gallagher et al of Mason Hayes and Curran.

Source: IMDRF

Team-NB
14 April 2025
Position Paper on IVDR Certification Process

Team-NB members a common paper aimed at describing in detail the pre-application and application and Post application phases processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/746 (IVDR).

Source: Team – NB

Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 V3

Team-NB members adopted the updated 3rd version of the notified bodies BPG harmonized approach to clarify information to be submitted by the manufacturer in their technical documentation.

Source: Team-NB

Team-NB statement on Certificates with Conditions
12 March 2025

Team-NB is the European Association for Medical Devices of Notified Bodies and is dedicated to ensuring a high level of patients’ safety and confidence.

  • The EU Medical Device Regulation (MDR) 2017/745 Annex VII section 4.8 allows the possibility of notified bodies to issue certificates with specific conditions, provisions or limitations.
  • The EU In-Vitro Medical Device Regulation (IVDR) also has similar clauses in Annex VII section 4.8
  • In August 2022, the EU Commission published guidance MDCG 2022-144, on exploring the use of certificates of specific conditions, provisions or restrictions noting that ‘the possibility for notified bodies to issue certificates under conditions or combined with the requirement to carry out PMCF / PMPF studies’. This work is still ongoing, and TEAM NB remains committed to supporting this initiative.
  • In line with this press release, Team-NB encourages all members in line with the published report by the Co-ordinating Research and Evidence for Medical Devices (CORE-MD) group on “Conditional Certification for High-Risk Medical Devices”, to continually consider the possibility of issuing certificates with specific conditions, provisions, or limitations to ensure that innovative, novel and orphan medical devices continue to be accessible to healthcare professionals and patients in the EU with appropriate surveillance safeguards in place.

Source: Team NB

UK
10 April 2025
Guidance updated – Clinical investigations for medical devices

This guidance has been updated to add new updated guidance for manufacturers.

The updates as detailed on page 3 of the guidance are as follows:

  • Clarification of term used in validation and their regulatory basis
  • Updates to reflect ‘participants’ as preferred terminology
  • Minor clarifications for readability

Source: MHRA

13 March 2025
Guidance updated- Export medical devices

This guidance has been updated as follows:

Updated version of Certificate of Free Sales Reference Guide: Clarification that CFS cannot be ordered for in vitro diagnostic medical devices for performance evaluation.

Source: MHRA

Guidance updated – Register medical devices to place on the market in GB and NI

This guidance has been updated as follows:

  • Clarification that if registered device characteristics change this may require re-registration, in which case the statutory fee will be payable.
  • Updated account management and device registration reference guides:
  • Inclusion of links to guidance for the EU IVDR transition extension under Article 110 for the registration of IVD devices with the MHRA.
  • Clarification concerning maximum validity for Letter of Designation.
  • Correction to countries that Northern Ireland Authorised Representatives can represent manufacturers from.

Source: MHRA

18 February 2025
Guidance updated – Register medical devices to place on the market

The web page now includes guidance for the EU IVDR transition extension under Article 110 for the registration of IVD devices with the MHRA.

Additionally, some minor updates have been made to the current guidance for medical device registration, specifically for devices captured under the EU MDR transition extension under Article 120.

Source: MHRA

7 January 2025
Guidance updated: Regulation of devices in Northern Ireland

There has been an update to the ‘Clinical investigations and performance studies in Northern Ireland’ section of this guidance.

Source: MHRA

European commission
10 April 2025
New publication of Harmonised standards under the medical devices Regulations – April 2025

You can view the above here.

Source: European Commission

6 February 2025
Pilot coordinated assessment for Clinical Investigations/Performance Studies

Member States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States as per Articles 78 of the Regulation (EU) 2017/745 (MDR) and 74 of the Regulation (EU) 2017/746 (IVDR) respectively.

  • This pilot will allow sponsors to submit a single application for pilot coordinated assessments, assuring more harmonised interaction with the Member States approving the clinical investigation or performance studies.
  • Additionally, participant sponsors will help the competent authorities of Member States with the building of a fast and fit for purpose EU system for coordinated assessment once its mandatory operation starts as required in Article 78 (14) MDR and Article 74 (14) IVDR (modified by Regulation (EU) 2024/1860, Articles 1(3) and 2(2) respectively).
  • The goal is to implement a harmonised, predictable process across Member States, reducing administrative burden for sponsors and ensuring high transparency and consistency in the coordinated assessment.

By participating in the pilot for coordinated assessment, sponsors can benefit in several ways which include:

  • Unified engagement: engage with all the EU countries involved, thus making communication more efficient and clearer while reducing delays.
  • More transparency and harmonisation: the pilot will enhance transparency, improving and giving sponsors better visibility of the evaluation process across EU countries by access to the operational procedures. Member States will work together becoming familiar with each other’s practices and particularities, thus increasing harmonisation.
  • Simplified requests for information: experience a more efficient request for information (RFI) process, reducing potential complexities compared to non-coordinated assessments.

For information on the following topics, click on the link below:

  • Who can apply and eligibility conditions
  • Participating Member States
  • Submission of an application
  • Selection
  • The Secretariat
  • Resources

Source: European Commission

Mexico
4 April 2025
COFEPRIS reports on the modifications to NOM-241-SSA1-2025, Good manufacturing practices for medical devices

COFEPRIS reports on the recent publication of the modification of the Mexican Official Standard NOM-241-SSA1-2025, Good manufacturing practices for medical devices, which establishes the minimum requirements for the design, development, manufacturing, storage, and distribution processes of these supplies.

  • The main modifications made to this NOM are the elimination of section 5, which referred to the classification of medical devices, which is not a requirement for compliance with good manufacturing practices and is also contained in the Pharmacopoeia of the United Mexican States (FEUM)
  • The clarification of the requirement for the annual product review (RAP) or the annual product quality review (RACP) in section 5.6.6.5, in order to indicate that depending on the nature of the medical device and based on risk management, it is possible to establish a different review frequency;
  • The issuance of section 11.4, which is specific to the requirements applicable to retention samples.
  • Reference was also made to the appendix entitled “Application of Risk Management to Medical Devices” of the Medical Device Supplement to the Mexican Pharmacopoeia (FEUM) in section 6.7 for the implementation of risk management; the creation of specific manufacturing lines for software as a medical device in section 11.16; and remanufacturing and refurbishment/rehabilitation in section 11.17.
  • Sections 14.1.6 and 14.1.7 were also amended to clarify the requirements applicable to stability studies and to reference the current version of the FEUM regulatory appendix on stabilities of medical device supplements.
  • Section 18, Good Storage and Distribution Practices, was amended to include specific requirements for backlabeling activities, as outlined in sections 18.5.2.4, 18.7.1.8, 18.7.1.9, and 18.8.3.

Source: Cofepris

South Africa
4 April 2025
SAHPRA joins the Medical Device Single Audit Programme (MDSAP)

SAHPRA has joined the Medical Device Single Audit Programme (MDSAP), an international audit programme of medicines and medical device regulators aimed at improving efficiencies in the regulation of medical device manufacturers by engaging in work sharing and collaboration.

SAHPRA joins MDSAP as an affiliate member, which expands its ability to monitor the manufacturing of medical devices beyond South Africa’s borders.

Source: SAHPRA

Switzerland
3 April 2025
Swissmedic becomes a member of the IMDRF Management Committee

Swissmedic has been accepted as a member of the Management Committee (MC) of the International Medical Device Regulators Forum (IMDRF).

  • The decision was made on March 14, 2025, during the 27th IMDRF meeting in Tokyo, Japan.
  • The IMDRF is an international platform composed of regulatory authorities from around the world.
  • Their common goal is to promote harmonization and cooperation in the field of medical device regulation.
  • IMDRF membership enables Swissmedic to play an even more active role in shaping the international regulatory landscape.
  • This benefits both authorities and economic actors, as increased harmonization of regulations leads to a reduction in regulatory burden and improved international recognition.
  • Swissmedic will continue to contribute its expertise and advocate for efficient, transparent, and risk-based regulation of medical devices.

Source: Swissmedic

17 February 2025
Review of post-market surveillance documentation by Swissmedic

Swissmedic checked compliance with the post-market surveillance requirements for 30 medical devices in risk classes IIa and higher under the old legislation.  You can view the results here. Note that the document is in German.

Source: Swissmedic

Ireland
27 March 2025
HPRA verification of economic operator registration details for medical device inspections

The HPRA is in the process of verifying the registration details of medical device economic operators prior to conducting inspections.

Those selected for this activity will receive an email from the HPRA directing them to complete a Microsoft Office Form.

The details requested in the form include, for example:

  • contact details,
  • the address of the registered business,
  • the roles undertaken by the EO,
  • the location(s) of any other associated businesses or outsourced activities.

Please complete the form in response to these requests in a timely manner and provide all relevant information.

Source: HPRA

European Medicines Agency
24 March 2025
EMA establishes regular procedure for scientific advice on certain high-risk medical devices

On 24 March 2025, EMA updated this news announcement (originally published on 10 Feb 2025) to include an interim report on the scientific advice pilot for high-risk medical devices. Find the report under ‘Related documents’ on this page.

EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation.

The advice procedure is available for two types of medical devices:

  • class IIb active devices – intended to administer or remove medicines
  • class III devices – invasive and sustain or support human life

Manufacturers of these devices can now submit their request for advice via a portal and consult the medical device expert panels at different stages of the clinical development.

Advice given by the medical device expert panels is a key tool to foster innovation and promote faster patient access to safer and more effective devices.

More information on the submission process, including step-by-step instructions for applicants and monthly submission deadlines is available on EMA’s website.

Manufacturers of high-risk medical devices intended for the treatment of a rare condition should apply for advice via the ongoing pilot programme to support orphan medical devices.

Source: EMA

Anvisa – Brazil
17 April 2025
Public consultation – Guide on forced degradation studies in medicines

Guide 79, dated March 28, 2025 – Version 1 published on 17 April concerns forced degradation studies on medicines and for the notification, identification and qualification of degradation products.

The document brings together Anvisa’s guidelines for meeting the requirements for conducting these studies, described in the Collegiate Board Resolution (RDC) 964/2025. 

Comments can be submitted using  this electronic form .

Consultation start date: 17 April 2025

Consultation end date: 13 October 2025

European Medicines Agency
14 April 2025
Consultation on a potential Key Information Section in the Package Leaflet of centrally authorised medicinal products

The EMA and the Quality Review of Documents (QRD) Working Group are currently working on the revision of the QRD template for centrally authorised medicinal products for human use, with the aim of improving the content and structure of the package leaflet and making it more understandable and relevant to patients, while still complying with the current legislative framework. The draft revised QRD template has been released for public consultation until 31 August 2025 (see consultation information below)

Separate from the public consultation of the QRD template, which can be accessed below, the EMA would like to gather the views of stakeholders on the potential usefulness and added value of a new “key information section” in the package leaflet.

The addition of this new section addresses one of the recommendations in the Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and it would allow patients, users and healthcare professionals to rapidly identify key safety messages, balanced with information on the benefit-risk profile of the medicine.

As concluded in the report, the evidence and views collected may help inform the decision on whether such a key information section in the package leaflet is needed and, if so, what type of information should be provided therein.

You can view the consultation here and respond to it here.

Consultation start date: 14 April 2025

Consultation end date: 31 May 2025

Source: EMA

Draft for public consultation- QRD annotated template v11

The EMA is revising the QRD template for centrally authorised medicines for human use mainly to improve the content and structure of their package leaflet.  

This aims to make the package leaflet more understandable and relevant to patients, while complying with the current legislative framework, Directive 2001/83/EC.

Main proposed changes include: 

•    Deleting or making certain text optional to shorten the leaflet
•    Creating standard statements to improve patient-friendliness and consistency across products
•    Relocating important information at the beginning of the leaflet
•    Clustering information by subject to make it easier to locate
•    Reorganising warnings / precautions in a more logical order

Here, you can view the track changed and clean versions Draft for public consultation.

Use the form at this link to submit your comments.

Consultation start date: 14 April 2025

Consultation end date: 31 August 2025

Source: EMA

1 April 2025
Draft Reflection paper on a tailored clinical approach in biosimilar development


A biosimilar is a biological medicine that is highly similar to an already approved reference medicine. While not identical, biosimilars offer the same clinical effectiveness and safety as their reference products. They play a critical role in improving patient access to life-saving treatments, including for diseases like cancer, rheumatoid arthritis, and inflammatory bowel disease.

  • The reflection paper suggests that structural and functional comparability, along with pharmacokinetic data, may be enough to demonstrate “similarity” to the reference medicine.
  • This could reduce the need for extensive clinical trials, streamlining the approval process.
  • The approach could potentially lead to quicker patient access to essential therapies, while ensuring Europe remains a competitive market for biosimilars.

Comments should be provided using this EUSurvey form.

Further reading

1) EMA to consult on biosimilars regulatory requirements in 2025 by Arjan Reijns et al, 21 November 2024, Pinsent Masons

2) EMA biosimilars policy shifts over clinical efficacy studies by Catherine Drew et al, 2 April 2025, Pinsent Masons

3) Streamlining development and assessment of biosimilar medicines, 1 April 2025, EMA

Consultation start date: 1 April 2025

Consultation end date: 30 September 2025

Sources: EMA, Pinsent Masons

31 March 2025
Draft Reflection paper on linking to electronic product 4 information (ePI) from EU medicine packages

This reflection paper describes components to be put in place to realise an EU-wide solution in which ePI could be easily accessed by citizens wherever they are in Europe, in their preferred language when available.

  • It calls on stakeholders to take action and invest in the development of such initiative at EU level, building on and complementing existing work to implement ePI in Europe.
  • Opportunities, limitations and other relevant considerations are outlined.
  • In addition, some existing EU and international examples are described.

Comments should be provided using this EUSurvey form.

Consultation start date: 31 March 2025

Consultation end date: 30 June 2025

Draft Reflection paper on the current regulatory testing 4 requirements for medicinal products for human use and 5 opportunities for implementation of the 3Rs

In December 2016, the CHMP and CVMP published the “Guideline on the principles of regulatory 36 acceptance of 3Rs (replacement, reduction, refinement) testing approaches” (EMA/CHMP/CVMP/JEG-37 3Rs/450091/2012).

  • This reflection paper has been developed as a follow-up to that guideline and provides an overview of the main animal tests required for the regulatory testing of medicinal products for human use (a parallel document has been developed in relation to veterinary medicinal products [EMA/CHMP/CVMP/JEG-3Rs/740772/2015]).
  • It includes information on opportunities for limiting animal testing that can already be implemented, where appropriate, as well as information on opportunities that may become available in the future.
  • It should be emphasised that the latter comprises areas that are currently under investigation and will necessitate data review and further discussion before a definitive impact on 3Rs can be appraised.
  • This document should encourage sponsors to develop new 3Rs methodologies and submit them for regulatory review and acceptance.

Consultation start date: 13 February 2025

Consultation end date: 30 June 2025

Source: EMA

Draft Reflection paper on the qualification of non-mutagenic impurities
30 January 2025

This reflection paper replaces a previous draft version (Reflection paper on the qualification of non-genotoxic impurities: EMA/CHMP/SWP/545588/2017).

The focus of this reflection paper is to provide alternative strategies to qualify novel impurities or to qualify higher levels of impurities that were previously qualified at a lower level. It considers that the level of concern for impurities may vary depending on many factors that determine how much data is needed, ranging from none to compound-specific experimental data.

Comments should be provided using this EU survey form.

Consultation start date: 30 January 2025

Consultation end date: 30 April 2025

Source: Anvisa

Malaysia
7 August
Announcement to Product Registration Holders (PRHs): Revision of Categories and Criteria for New/Additional Indication Application – A Pilot Study

As the NPRA progresses towards implementing reliance throughout the product life cycle, it plans to expand the implementation of reliance to include new/additional indication applications beginning with a pilot project.

  • For this pilot project, the NPRA have revised the current categories and their criteria as in Appendix I. 
  • As this is a pilot project, the proposed estimated timeline for Additional Indication (AI) Full-reliance as detailed in Appendix I represents the best commitment NPRA can make under the current circumstances to test out new processes and requirements.
  • A checklist to be completed by applicants is also provided.
  • In addition to the AI applications, the NPRA is handling a high volume of variation applications, all with the same staff and resources.
  • NPRA is also working to streamline the variation process and seeks your assistance in properly planning and scheduling your variation submissions. This may help reduce the NPRA workload and consequently improve the timeline for new AI applications.

Pilot study start date: 1 August 2024

Pilot study end date: 31 July 2025

Source: NPRA

Brazil
27 March 2025
Anvisa public consultation on database for Unique Identification of Medical Devices

Anvisa has opened a public consultation to receive contributions on the requirements for transmission and management of the Brazilian database on Unique Identification of Medical Devices – UDI.

  • Unique Device Identification ( UDI ) is an international identification standard that aims to facilitate the identification of medical devices on the market, mainly aiming to increase patient safety.
  • The UDI was established  by RDC No. 591/2021 .
  • The regulation currently under public consultation is the proposed normative instruction that deals with the basic conditions for sending UDI data to Anvisa.
  • The Agency confirmed that the database, which will be called the Single Device Identification System – SIUD, is now ready to receive data from companies.
  • It is important to note that sending UDI data to Anvisa’s database will not become mandatory immediately after this Normative Instruction comes into effect.
  • The deadlines for mandatory submission are established in RDC No. 591/2021 and will be counted from the entry into effect of the new Normative Instruction that is under public consultation:
    • 3.5 years for class IV devices;
    • 4 years for class III;
    • 5 years for class II; and
    • 6 years for class I;

Consultation start date: 27 March 2025

Consultation end date: 26 May 2025

Source: Anvisa

Singapore
10 March 2025
Public Consultation on Best Practices Guide for Medical Device Cybersecurity

The Medical Devices Cluster (MDC) has released a draft on Best Practices Guide for Medical Device Cybersecurity for stakeholders’ consultation.

  • This document provides best practices recommendations and considerations to all medical device manufacturers and healthcare providers on general cybersecurity principles to ensure medical devices are secure throughout the Total Product Life Cycle (TPLC).
  • Stakeholders are invited to provide feedback on the Best Practices Guide for Medical Device Cybersecurity:

Please provide your feedback using the prescribed template and upload into the online form https://go.gov.sg/md-best-practices-for-consult

Consultation start date: 10 March 2025

Consultation end date: 12 May 2025

Source: HSA

UK
26 February 2025
Response to Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices

The MHRA has published the first part of the Government response to its recent medical devices regulations consultation which ran from 14 Nov 2024 to 5 Jan 2025..

  • Respondents were in favour of retaining four pieces of EU law until new regulations are put in place. This will avoid creating a gap in regulation that could have a serious impact on patient safety.
  • Legislation will be laid in Parliament soon, to make provisions for retaining these EU regulations until they are no longer needed.
  • The MHRA response to the other aspects of the consultation requires more in-depth analysis and will be published separately in due course.

Source: MHRA

Fimea – Finland
11 April 2025
New Cybersecurity Act enters into force

The new Cybersecurity Act entered into force on 8 April 2025.

  • The Cybersecurity Act implements the EU’s NIS2 Directive.
  • The aim of the new legislation is to ensure that there is a common level of cybersecurity across the European Union.  

The Act introduces new obligations for several sectors, including operators supervised by the Finnish Medicines Agency (Fimea). The new obligations include:

  • an obligation to register as an operator with Fimea within a month of the Act’s entry into force,
  • cybersecurity risk management obligations and
  • cybersecurity incident reporting obligations.

According to the Cybersecurity Act, the following key operators will be subject to Fimea’s control in Finland, among others: 

  • manufacturers of medicinal substances and medicines,
  • manufacturers of medical devices and in vitro medical devices for diagnostics,
  • blood establishments,
  • operators involved in the research and development of medicines,
  • pharmacies and
  • other potential medical device operators as specified in more detail in the Cybersecurity Act.

Control measures relate in particular to large and medium-sized enterprises, more precise definitions of which can be found in the Cybersecurity Act. 

Source: Fimea

MHRA – UK
9 April 2025
WHO confirms that the MHRA is to continue playing vital role in ensuring the quality of global biological medicines  

The WHO has confirmed the successful redesignation of the MHRA’s Science and Research group as one of its Collaborating Centres for the Standardisation and Evaluation of Biologicals for the next four years.   

MHRA experts carry out four main responsibilities:

  • Supporting WHO in developing, producing, and distributing international standards and reference materials for quality control and assurance of clinically relevant biological materials.  
  • Conducting collaborative research to assure the quality of vaccines and other biologicals.  
  • Providing technical input that may inform WHO when developing international written standards and guidelines for production and quality control of vaccines and other biologicals.  
  • Contributing to WHO’s regional work to assure the quality and safety of vaccines and other biologicals through the provision of technical support and technical assistance to build capacities.

Source: MHRA

European Medicines Agency
7 April 2025
Adopted – Final reflection paper on use of real-world data in noninterventional studies to generate real-world evidence for regulatory purposes

The EMA has provided a heads up for all stakeholders involved in non-interventional studies using real-world data (RWD) to generate real-world evidence (RWE) for regulatory purposes in the EU.

  • The final reflection paper outlining key principles for conducting and assessing non-interventional studies using RWD has been published. It was adopted on 17 March 2025 by CHMP PROM.
  • These studies can complement data from clinical trials and fill in knowledge gaps. However, understanding the limitations and overcoming them is key to ensuring reliable evidence.
  • The paper covers legal obligations and regulatory requirements, study design, bias, confounding and effect modification, governance and transparency, data quality and statistical analyses.
  • It’s part of the newly published roadmap for regulatory guidance on RWE.

Source: EMA

3 April 2025
Clinical Trials Information System (CTIS) designated as WHO primary registry

The Clinical Trials Information System (CTIS) has been designated as a primary registry by the World Health Organisation (WHO) within the International Clinical Trials Registry Platform (ICTRP).

  • Becoming a primary registry means CTIS adheres to specific criteria for content, data quality and validity, accessibility, unique identification, technical capacity, and administration.
  • This ensures comprehensive research information is accessible to healthcare decision-makers globally.
  • CTIS has already been a registered data provider for WHO since May 2023
  • Designation as a primary registry represents a significant milestone in facilitating data sharing and promoting transparency and trust in clinical research.

Source: EMA

European Commission
11 March 2025
Commission proposes Critical Medicines Act (CMA) to bolster the supply of critical medicines in the EU

Today, the Commission proposed a Regulation to improve the availability of critical medicines in the EU.

  • The proposal aims to protect human health by incentivising supply chain diversification and boosting pharmaceutical manufacturing in the EU. 
  • This will support the EU’s pharmaceutical sector which is a major contributor to our economy.
  • The Act also aims to improve access to other medicines of common interest, which may not be available in certain markets.
  • This initiative contributes to the European Health Union’s goal of ensuring that EU patients have access to the medicines they need, when they need them.

The proposal will now be discussed by the Council of the European Union and the European Parliament, with potential amendments and final adoption of the CMA which is expected by the end of 2025.

You can read more about the proposal here.

Source: European Commission

DateEvent
11 April 2025UKNew UK clinical trials regulations signed into law. More information in this post.
26 Mar 2025EUEuropean Health Data Space Regulation (EU) 2025/327 entered into force.

You can read about it in this post by J. Grieb ety al. of McDermott Will & Emery.
31 Jan 2025EUFrom this date, the clinical trials regulation 536/2014 becomes applicable. All clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are now governed by the Clinical Trials Regulation (EU) No 536/2014
(CTR).

This marks the end of a three-year transition period, during which more than 5,000 clinical trials were transitioned to the CTR through submission to the Clinical Trials Information System (CTIS), the single-entry point for sponsors and regulators for the submission and assessment of applications for clinical trials in the EU.

Further information is available form the EMA here and in this blog post.
30 Jan 2025UKNew Innovatiive Licensing and Access Pathway (ILAP) launched.
1 Jan 2025UKWindsor framework comes into operation. More information in this blog post and this blog post.
1 Jan 2025EUAmended Variations Regulation (EU) 2024/1701 implemented. more information in this blog post.
Switzerland
22 April 2025
Public consultation on ICH Guideline M13B “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” launched in Switzerland
  • Current regional or multi-regional guidelines have different views and criteria regarding design of bioequivalence (BE) studies and data analysis.
  • This lack of harmonisation can result in product developers having to follow different approaches in different regions and conducting additional BE studies, hampering streamlined global drug development.
  • Part of the planned ICH M13 Guideline series (M13A-C), the ICH M13B Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
  • The ICH M13B Guideline is the first Guideline in the foreseen series to describe the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms.
  • Comments can be provided using the feedback form specified by ICH to networking@swissmedic.ch.

Consultation start date: 22 April 2025

Consultation end date: 9 July 2025

Source: Swissmedic

24 February 2025
Introduction of the ICH GCP E6 (R3) guideline

On January 6, 2025, the principles and Annex 1 of the revised ICH GCP E6 (R3) guideline were adopted at international level.

  • These will enter into force in the EU region on July 23, 2025.
  • Switzerland will align with this schedule and allow the principles and Annex 1 to enter into force in summer 2025.
  • Annex 2 will be adopted at a later date and will enter into force in the EU and Switzerland at the earliest in early 2026.

Source: Swissmedic

European Medicines Agency
9 April 2025
Public consultation – ICH M13B Guideline on bioequivalence for immediate release solid oral dosage forms – additional strengths biowaiver Step 2b

This guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths.

  • The guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
  • M13B, the second guideline in the series, describes the scientific and technical aspects of ICH M13B Guideline demonstrating BE for additional strengths of a drug product, i.e., obtaining waiver(s) for one or more strengths in an application with multiple strengths when BE has been demonstrated for at least one of the strengths following ICH M13A.
  • M13B describes the additional strength(s) biowaiver criteria as they relate to a) the dose proportionality in the PK of the drug (or drugs in the case of fixed dose combination (FDC) products), b) the formulation proportionality of the drug substance(s) and excipients in the additional strength(s) compared to the biobatch strength, and c) the similarity in dissolution profiles between the additional strength(s) and the biobatch strength as demonstrated in the dissolution conditions described in this guideline.

Comments should be provided using the template link provided in the guideline.

Consultation start date: 9 April 2025

Deadline for comments: 9 July 2025

Source: EMA

Brazil
27 March 2025
Electronic Harmonized Structured Clinical Protocol Guide Receives Contributions (in connection with ICH M11)

Anvisa published  Call Notice 4/2025 , to collect contributions to the Technical Specification Guide for Electronic Structured Clinical Protocol (CeSHarP), from ICH EWG M11 (International Council for Harmonization of Technical Requirements for Pharmaceutical Products for Human Use).

The proposed text of the ICH EWG M11 guideline is available on the ICH website at: 
https://database.ich.org/sites/default/files/ICH_M11_Technical%20Specification_Updated%20Step%202_2025_0203.

Any interested party may make contributions to the document, especially:

  • sponsors of clinical trials,
  • Clinical Research Representative
  • CROs
  • research center teams,
  • representatives of Ethics Committees,
  • professors and researchers in the field, or
  • anyone involved with the clinical development and registration of drugs and biological products.

To contribute, it is recommended to observe the following points:

  • Prioritize or highlight key comments.
  • Correlate your comment with the corresponding line number in the guide to make it easier to identify the text.
  • Provide justification and any relevant examples to support the suggested changes.
  • Suggest new writing whenever possible.
  • Consolidate comments from the same organization, if appropriate.
  • Write your comment preferably in English.

Contributions must be made using a specific electronic form, available at  
http://pesquisa.anvisa.gov.br/index.php/237591?lang=pt-BR

Consultation start date: 27 March 2025

Consultation end date: 28 April 2025

Source: Anvisa

European Medicines Agency
20 March 2025
EMA qualifies first artificial intelligence (AI) tool to diagnose inflammatory liver disease (MASH) in biopsy samples

EMA’s CHMP has issued the first Qualification Opinion (QO) on an innovative development methodology based on artificial intelligence (AI).

  • The tool, called AIM-NASH, helps pathologists analyse liver biopsy scans to identify the severity of MASH (metabolic dysfunction associated steatohepatitis; formerly known as non-alcoholic steatohepatitis NASH) in clinical trials.
  • AIM-NASH is an AI-based system that employs a machine learning model trained on more than 100,000 annotations from 59 pathologists who assessed over 5,000 liver biopsies across nine large clinical trials.
  • The qualified tool is ‘locked,’ which means the machine learning model cannot be modified or replaced. CHMP encourages the optimisation of the model, acknowledging that major changes may require re-qualification of the tool.
  • MASH is a condition where fat builds up in the liver, causing inflammation, irritation and scarring over time, without significant alcohol use or other reasons for liver injury.
  • The AIM-NASH tool is expected to enhance the reliability and efficiency of clinical trials for new MASH treatments by reducing variability in measuring disease activity (inflammation and fibrosis).
  • Following a public consultation, CHMP issued an opinion to qualify this method, which means that the committee can accept evidence generated by the tool as scientifically valid in future applications. 
  • CHMP agreed that the tool can increase reproducibility and repeatability in assessments for new MASH treatments.
  • It can help researchers obtain clearer evidence on the benefits of new treatments in clinical trials that include fewer patients. Ultimately, this can bring effective treatments to patients faster.

Source: EMA