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
13 May 2025
Guidance updated – International Recognition Procedure (IRP)
The validation checklist for the procedure has been updated. You can the updated checklist here.
You can read more about the IRP in this blog post.
Source: MHRA
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
Turkey
5 May 2025
Clinical research documents updated
The following documents have been updated and must now be used as of 2 May 2025:
- Responsible Investigator Responsibility Transfer and Acceptance Document
- Coordinator Investigator Responsibility Transfer/Acceptance Document
- Protocol Signature Page
Source: TITCK
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
Switzerland
1 May 2025
Risk assessment regarding nitrosamines in active substances and/or finished medicinal products
Swissmedic enshrines the requirement to submit risk assessments regarding nitrosamines in active substances and/or finished medicinal products in the relevant specification documents.
- The guidance document Formal Requirements is supplemented by Chapter 2.5.16 Risk assessment regarding nitrosamines in active substances and/or finished medicinal products .
- This document specifies for which new marketing authorisation applications, Swissmedic requires a risk assessment of nitrosamines in the active ingredient and/or finished medicinal product, and which exceptions apply.
- For example, these risk assessments are always required if the active ingredient of the newly approved human medicinal product is chemically synthetic or contains synthetic components.
- New marketing authorisation applications for co-marketing medicinal products, for example, are exempt from the requirement to submit nitrosamine risk assessments.
- In the “New Marketing Authorization” tab of the list of documents to be submitted , the added item 1.12.5 also clarifies that Swissmedic expects the risk assessment in Module 1 and to which specific new marketing authorization applications this requirement applies.
- These formal requirements also apply in the EU.
- The above-mentioned standard documents entered into force in an adapted version from 1 May 2025.
Source: Swissmedic
Parallel import: Updates to the guide and the form
The guidance on importing a human medicinal product according to Article 14 paragraphs 2 and 3 of the TPA (parallel import) is clarified and adapted in some points.
- An application for approval of a parallel-imported human medicinal product can only be accepted if the original medicinal product is authorized in Switzerland at the time of submission.
- The post-market requirements regarding quality, safety, and efficacy are specified.
- For example, if safety signals or quality defects are present in the original medicinal product (e.g., elevated nitrosamine levels), the importer may be required to implement any risk-minimizing measures.
- The number of samples to be submitted is reduced to 1 sample pack per dosage strength.
- The requirements regarding the GTIN code and LOT number are described in more detail.
- The Swiss marketing authorization number and the package code must always be included, either within the GTIN code or as a separate text.
- Further clarifications concern the marketing authorization status, such as the impact of a revocation/suspension of the original medicinal product on the parallel-imported medicinal product, as well as the consequences of a sales interruption for the original medicinal product.
- The adapted guideline Import of a human medicinal product according to Art. 14 Para. 2 and 3 TPA (parallel import) and the adapted form Import of a human medicinal product according to Art. 14 Para. 2 and 3 TPA (parallel import) are valid from1 May 2025
Source: Swissmedic
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.
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
USA
15 April 2025
eCTD submission standard update
The FDA has posted updates on the following:
- eCTD Submission Standards for eCTD v4.0 and Regional M1. You can view it here.
- eCTD Submission Standards for eCTD v3.2.2 and Regional M1. You can view it here.
Source: FDA
6 May 2025
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
The U.S. FDA announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients.
- This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.
- In addition, the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight.
- These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process.
Source: FDA
Further reading:
FDA announces expanded use of unannounced inspections at foreign manufacturing facilities, Hogan Lovells 8 May 2025.
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
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
Australia
30 April 2025
Nitrosamine impurities acceptable intakes update
The TGA has published updated information for nitrosamine impurities in medicines consistent with recent EMA updated information – external site.
- The changes include minor editorial amendments and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines.
- The AI changes are tabulated on the updates to nitrosamines and other nitroso-structures page.
- Sponsors and manufacturers are expected to be familiar with the current AIs for nitrosamine impurities and other nitroso-structure impurities in medicines.
Source: TGA
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:
- for nonclinical safety matters when submitting the initial clinical trial notification (Early Consideration)
- for the discussion with PMDA using the ICH S1B (R1) guideline and in the approval application (Early Consideration)
- in Developing Drugs for Pediatric Inflammatory Bowel Disease (Early Consideration)
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
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.
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, whereby 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
UK
16 May 2025
Guidance – Manufacturer’s Online Reporting Environment (MORE)
The MHRA has published new implementation guidance to help medical device manufacturers prepare for changes to reporting requirements for serious safety incidents and field safety corrective actions in Great Britain (GB).
- The new implementation guide for the Manufacturers Online Reporting Environment (MORE) clarifies the changing data requirements and timelines for compliance, before the new post-market surveillance regulations for medical devices come into effect on 16 June 2025.
- Manufacturers should be aware of the following important dates:
- early June – MHRA will release an updated schema and guidance for Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs), for the upcoming GB reporting requirements
- 16 June – the new GB MIR and FSCA schema will be available in our MORE system, for manufacturers to us
- 6 October – the latest date that manufacturers must start using the new GB schema to report incidents to MORE [via API (application programming interface) or post eXtensible Markup Language (XML) routes]
- Reports for Northern Ireland may continue to be reported to the MHRA using the existing MIR 7.2.1 after 16 June 2025.
Source: MHRA
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
Source: MHRA
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
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
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
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
European Medicines Agency
8 May 2025
Public consultation – Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products
This concept paper aims to outline the rationale, objectives, and proposed changes for updating Part IV – GMP specific to ATMP of the good manufacturing practice (GMP) guide Eudralex Volume 4 following the revision of Annex 1 which came into operation in August 2023.
As the Part IV is an EU standalone guideline and that the sector is to abide solely for reference, it should be revised independently to address recent developments in the manufacture of sterile medicinal products.
Those participating in the public consultation are asked to please submit comments via the EU Survey tool at this link.
Consultation start date: 8 May 2025
Consultation end date: 8 July 2025
Source: EMA
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
CDSCO – India
6 May 2025
Consultation on Revised Guidelines on Similar Biologics – Regulatory requirements for Marketing Authorization in India
In view of advances in scientific knowledge and experience, CDSCO decided to revise the
existing guidelines in line with recent international quidelines.
- The Draft Guidelines are now being placed in the public domain to invite comments/suggestions from relevant stakeholders.
- This window of opportunity will close within 30 days of publishing the draft guidelines on CDSCO website, and, once finalized there will be minimal scope for change in this document.
- All interested stakeholders are requested to provide comments/suggestions at biological@cdsco.nic.in in word document as per the annexed format.
- Suggestions/comments will be taken into consideration before finalisation of the Guidances document.
Consultation start date: 6 May 2025
Consultation end date: 5 June 2025
Source: CDSCO
Anvisa – Brazil
5 May 2025
CMED public consultation on drug pricing criteria
The Executive Technical Committee of the Chamber for the Regulation of the Drug Market (CTE/CMED) will begin a public consultation on 12 May 2025 to review CMED Resolution 2/2004, which establishes the criteria for setting prices for new products and new presentations of drugs and the procedure for submitting the Price Information Document (DIP).
- The objective is to update the standard, ensuring greater clarity and predictability in CMED procedures.
- The changes also aim to accommodate innovation in the pharmaceutical sector, resulting from the advances achieved over the last 20 years.
- In this sense, specific rules are being incorporated for the pricing of radical and incremental innovation products, according to the clinical benefit provided and the degree of innovative activity undertaken in the country for the development of the product.
- The draft of the public consultation includes other advances for the pricing of medicines in Brazil, such as updating the basket of countries for external price referencing, clear definition of procedural rites, incorporation of rules currently provided for in communications, inclusion of definitions applicable to the resolution, rules for the application of provisional prices, as well as other aspects for improving the regulation of the national pharmaceutical market.
- The initiative seeks a solution that adheres to good regulatory practices and the provisions of Law 10.742/2003, in order to promote greater access by the population to innovative medicines and sectoral development, reconciling the interests of companies and citizens and generating investments for the country.
- Further information, including the Regulatory Impact Analysis Report (AIR), is available at this link.
Public Consultation 1,330/2025 establishes a 60-day deadline for submitting comments and suggestions on the text of the proposal. - Interested parties may submit contributions using the electronic form available on the consultation page.
Consultation start date: 12 May 2025
Consultation end date: 11 July 2025
Source: Anvisa
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
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
Spain – AEMPS
13 May 2025
AEMPS launches MeQA, a pioneering AI tool for answering questions about medicines for human use
AEMPS recently launched MeQA , a pioneering tool based on artificial intelligence that allows users to perform natural language queries on medicines for human use, obtaining immediate responses based on official information extracted from product information leaflets.
- MeQA allows you to perform natural language queries on medicines for human use and obtain immediate answers based on official information from product information leaflets.
- The objective of this tool is to help citizens better understand what medications they take, why they take them and how they should do so.
- This search engine represents a significant advance in transparency, improving access to reliable and quality health information.
Source: AEMPS
FDA – US
8 May 2025
FDA Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline
In a historic first for the agency, FDA Commissioner Martin A. Makary announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.
- The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.
- To reflect the urgency of this effort, Dr. Makary has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June 2025.
- Work will continue to expand use cases, improve functionality and adapt to the evolving needs of each center after June 30.
- By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.
- Looking ahead, the FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.
- Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.
Source: FDA
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
| Date | Event | |
|---|---|---|
| 11 April 2025 | UK | New UK clinical trials regulations signed into law. More information in this post. |
| 26 Mar 2025 | EU | European 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 2025 | EU | From 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 2025 | UK | New Innovatiive Licensing and Access Pathway (ILAP) launched. |
| 1 Jan 2025 | UK | Windsor framework comes into operation. More information in this blog post and this blog post. |
| 1 Jan 2025 | EU | Amended Variations Regulation (EU) 2024/1701 implemented. more information in this blog post. |
Switzerland
12 May 2025
Public consultation for ICH Guideline Q1 “Stability Testing of Drug Substances and Drug Products” launched
Swissmedic has launched the public consultation on Guideline Q1 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines).
- Most regulatory authorities successfully implement the ICH Q1 series (Q1A-Q1E), ICH Q5C, and the WHO stability guidance covering Climatic Zones III and IV (i.e., content of the withdrawn ICH Q1F) in the regulatory framework.
- However, experience gained with implementation since the time these guidelines were finalised shows there are uncertainties related to the interpretation of the individual guidelines and how they fit together.
- Additionally, it is recognised that innovation in analytical testing, including approaches as described in ICH Q2 and ICH Q14, along with the development of control strategies (ICH Q8 and Q11), Quality Risk Management principles (ICH Q9) and lifecycle approaches (as addressed in ICH Q10 and ICH Q12), create additional uncertainty for industry and regulatory agencies regarding how these pieces contribute to the assessment of product stability.
- Through reorganisation into a combined core guideline ICH Q1 with topic-specific annexes/appendices, the updated Q1 Guideline will address specific topics beyond the core stability recommendations and principles (e.g. intermediates, devices, enhanced modelling).
- The revision aims to promote harmonised interpretation by addressing potential gaps and areas of ambiguity, while also addressing technical issues around stability strategies, innovative tools for the application of risk management and stability considerations for advanced therapies.
- Comments can be sent using the feedback form specified by ICH to networking@swissmedic.ch.
- Links to the guideline and feedback form can be found at this link.
Source: Swissmedic
Consultation start date: 12 May 2025
Consultation end date: 30 July 2025
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
UK
8 May 2025
Consultation on the ICH M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The MHRA is consulting with UK stakeholders on the M13B guideline will focus on providing recommendations on obtaining waivers of 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 (‘in vivo’ refers to a medical test, experiment, or procedure that is done on (or in) a living organism, such as a laboratory animal or human). See the draft M13B guideline.
Source: MHRA
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
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