International regulatory news in brief

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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.

Turkey
23 September 2025
Guidelines for Applications for GMP Inspections of Overseas Manufacturing Facilities

The “Guidelines for Applications for GMP Inspections of Overseas Manufacturing Facilities” published on TITCkks official website on June 7, 2024, has been updated.

  • The updated guidelines entered into force on 22 September  2025.
  • Applications submitted before September 24, 2025, will be processed according to the previous version, while applications submitted on or after September 24, 2025, will be evaluated in accordance with the update guidelines.

Further information is available at the link below.

Source: TITCK

1 August 2025
e-CTD License Application Tracking” screen

As is known, studies are being carried out to standardize the information by obtaining license application information from the Institution’s database, to reduce the margin of error by moving the application form to an electronic environment, and to digitalize processes in order to allow work and transactions in license applications to proceed more quickly.

In this context, the “e-CTD License Application Tracking” screen, located under the “Applications” tab in the Electronic Application and Process Management System (EBS-ESY) module, has been made available to license applicants in order to enable them to track the processes related to their products currently in the licensing process.

2 July 2025
Attention Clinical Trial Parties – About Commissioning Notices in Clinical Trials

With the ‘Regulation Amending the Regulation on Clinical Trials of Medicinal Products for Human Use’ published in the Official Gazette dated 05 June 2025 and numbered 32921, the fourth paragraph of Article 35 of the Regulation published in the Official Gazette dated 27/5/2023 and numbered 32203 has been amended as follows:

“(4) Before their assignment in the research team; information on the investigators shall be notified to the ethics committee and the Agency, and information on the auxiliary clinical research personnel shall be notified to the ethics committee. Information on auxiliary clinical research personnel shall also be submitted to the Institution if requested by the Institution.”

For clinical trials authorised to start by the Clinical Trials Department;

  • Only investigator assignment notifications must be submitted to the Institution via the Clinical Trials Module (by mail for academic research).
  • Notifications regarding other assignments other than the investigator, such as research nurse, research pharmacist, field officer, monitor, auxiliary research staff assignments should not be made to the Institution at the current situation. However, this information should be submitted to the Agency if requested by the Agency (by Guideline, announcement, etc.).
  • In the Clinical Trials Module, technical work is ongoing to close the fields for notifications other than the investigator.

There is no change in the assignment notifications to be made to the ethics committees

Source: TITCK

UK
9 September 2025
Form updates: Medicines: variation forms for a manufacturer’s licence

The following documents have been updated:

Source: MHRA

2 September 2025
Guidance updated: Medicines: apply for a parallel import licence

The TaD cover sheet for PLPI companies has been updated.

TaD (Tell and Do variations) is a procedure which allows you to submit a variation for a change to the imported product and/or your parallel import licence particulars and then continue repackaging and distributing the product while the variation is assessed by the MHRA.

Source: MHRA

22 August 2025
Guidance updated: Clinical trials for medicines: apply for authorisation in the UK

According to the MHRA there has been an update to the information in the section In Vitro Diagnostic (IVD) Devices including Companion Diagnostic Devices. No further specifics have been provided.

Source: MHRA

14 August 2025
Guidance updated: Cancel a medicine’s marketing authorisation or other licence

The application for accompanying this guidance has been updated. You can view the updated cancellation form here.

Source: MHRA

8 August 2025
MHRA designated as WHO-Listed Authority

The MHRA announced its designation as a WHO-Listed Authority (WLA), joining the ranks of the world’s most trusted regulatory bodies. This recognition affirms MHRA’s commitment to the highest international standards in the regulation of medical products and marks a significant milestone for the UK’s leadership in global health. 

Source: MHRA

6 August 2025
Patients to receive medicines 3-6 months faster under 10-Year Health Plan

The MHRA and NICE described how the 10-Year Health Plan will lead to faster medicines access for patients in the NHS in England.

  • Under a joint information sharing agreement, pharmaceutical companies will be invited to register early with both agencies to allow parallel decision making over licensing and value.
  • It will mean more medicines receive approval for use on the NHS in England at the same time as they are licensed for use in the UK.
  • It’s anticipated that patients in England will receive the newest medicines 3-6 months earlier as a result.
  • Part of the 10-Year Health Plan and industrial strategy, the new joint service reflects the government’s commitment to smarter regulation, with a target to cut administrative costs for businesses by 25%.
  • The enhanced coordinated approach offers medicine developers an integrated advice service and an aligned pathway to help them streamline both regulatory and Health Technology Assessment (HTA) requirements and provides a clearer route to help get their treatments to patients.    
  • To benefit from this service, companies should register their products on UK PharmaScan, the national horizon scanning database, at least three years before their expected marketing authorisation.

Source: MHRA

17 July 2025
Updated guidance: Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing

In the above guidance, CESP submission codes for EU licences where Northern Ireland is CMS have been updated.

Source: MHRA

14 July 2025
Updated Forms: Medicines: variation forms for a manufacturer’s licence

The following updated forms have been published:

Source: MHRA

Switzerland
1 September 2025
Swissmedic requests marketing authorisation holders to review their medicinal products with genotoxic potential and, if necessary, to submit an application to update the medicinal product information.
  • According to the guidance document Product information for human medicinal products, the current applicable recommendations issued by EMA (SWP/NcWP recommendations on the duration of contraception following the end of treatment with a genotoxic drug [EMA/CHMP/SWP/74077/2020]) should be consulted as regards duration of contraception after treatment with medicinal products with genotoxic potential (e.g. oncologicals) has ended.
  • These recommendations were updated and clarified in 2023 as part of revision 1.
  • Swissmedic asks marketing authorisation holders to review their medicinal products with genotoxic potential and, in the event of discrepancies with the revised EMA recommendations, to modify accordingly, the information in the medicinal product information concerning duration of contraception following the end of treatment.
  • The modification should be made with the next regular type II variation to the medicinal product information, but no later than 30 September 2026.
  • If the modification is submitted as a separate application, a variation C.I.z type IB should be used.

Source: Swissmedic

General aspects to consider for FIH/early phase I clinical trials with medicinal products -position paper

Swissmedic has published version 2 (1 September 2025) of the above position paper.

  • During clinical trials with medicinal products in early development phases (i.e. first in human application, early phase I studies) new investigational medicinal products are examined for the first time in humans.
  • Initial insights are collected on their tolerability and safety.
  • To ensure the protection of the trial participants to the greatest extent possible, special aspects have to be considered during the planning and conduct of such clinical trials by the sponsors and participating clinical trial centres.
  • With this position paper, Swissmedic and swissethics aim at highlighting several important points to consider in the management and practical conduct of FIH/early phase I trials.

Source: Swissmedic

1 July 2025
Update to the guidance document “RMP ICH E2E Information for submission HMP”

The guidance document RMP ICH E2E Information for submission HMP has been thoroughly revised and supplemented.

  • Training materials will henceforth be referred to as educational materials.
  • At the same time, officially ordered educational materials will be defined and described and the identification of these materials specified.
  • With effect from 1 July 2025, educational materials that are officially ordered for the first time will have to be identified with the “Blue safety information” symbol.
  • A transitional period applies to existing officially ordered educational materials.
  • With immediate effect, the latest RMP approved by the reference authority must be submitted in Module 1.8.2 for authorisations under Art. 13 TPA.
  • If the reference authority is the FDA, an RMP should also be submitted in Swiss Module 1.8.2.
  • If EU RMPs are involved, standalone RMPs should always be submitted to Swissmedic only after they have been approved by the EMA.
  • The revised guidance document (version 6.0) RMP ICH E2E Information for submission HMP is valid with effect from 1 July 2025.
  • All the changes to the guidance document are detailed on page 18.

Source: Swissmedic

European Medicines Agency
23 September 2025

The Commission, HMA and EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition to make the European Union (EU) a more attractive destination for clinical research and improve timely access to innovative medicines for patients.

In five years, the aim is that:

  • An additional 500 multinational clinical trials are added to the current average of 900 that are already authorised each year (i.e. an estimated 100 per year).
  • Two thirds (66%) of clinical trials should begin recruiting patients within 200 calendar days or less from the date of application submission. This is in comparison to only 50% of clinical trials today.

These ambitious goals build on ongoing efforts to create a more supportive environment for clinical research. A key part of this is the Accelerating Clinical Trials in the EU (ACT EU) initiative, a collaboration between EC, HMA and EMA, which seeks to optimise how clinical trials are designed and run.

Source: EMA

Spain
8 September 2025
AEMPS expands accelerated evaluation procedure in early-stage trials

AEMPS has expanded its accelerated evaluation procedure with the aim of continuing to make Spain an increasingly attractive and competitive place for the research of medicines.

  • This accelerated assessment will now also apply to all national trials in oncology and rare diseases, phase 1, which investigate a medicinal product of biological origin.
  • Promoters must submit the application through the Clinical Trial Information System (CTIS) only in Spain.
  • These applications will be validated expeditiously and evaluated in 26 days instead of the usual 45 days.
  • In addition, promoters should select a Committee on Research with Medicinal Products (CEIm) attached to the fast-track procedure.
  • The contact details of these CEIm are available in the CEIm Board accredited in Spain.
  • In order to avail themselves of this procedure, the promoters concerned must contact the AEMPS before submitting the application by sending an e-mail to aecaem.aemps.es.
  • This mail should include the expected date of dispatch, the evaluator CEIm and the characteristics of the test: title, indication, research medicine, population and all additional information justifying compliance with the requirements for access to the accelerated evaluation procedure.
  • When submitting the application, they must indicate in the accompanying letter that adherence to the fast-track procedure has been accepted by the EMSA.

Source: AEMPS

27 June 2025
Recommendation for the use of the electronic form (eAF) for processing variations in medicinal products for human use authorized by non-centralized procedure (non-CAP)

AEMPS reports on the recommendation issued by the EMA to use the electronic application form (eAF), accessible via the PLM Portal , to process variations in medicinal products for human use authorized by non-centralized procedures (non-CAP), provided that it is technically feasible.

  • This recommendation, issued in May 2025, is part of the  timeline and implementation plan established for the mandatory adoption of the web-based eAF and applies to medicinal products authorized through the national (NAP), mutual recognition (MRP), or decentralized (DCP) procedures.
  • During the current transition phase, use of the web form is highly recommended.
  • However, applicants may continue to use the  interactive PDF form if they have not yet adapted their internal processes or if there are justified technical limitations.
  • Both formats will remain available temporarily to facilitate a smooth transition.
  • The eAF usage level established in the PLM Portal is structured in four phases.
    • In the first, optional use phase, applicants can freely choose between the PDF form and the web-based eAF.
    • In the second, recommended use phase, the use of the web-based eAF is encouraged, although the PDF format is not excluded.
    • In the third, highly recommended use phase, widespread use of the web-based eAF is expected, except in exceptional cases for technical reasons.
    • Finally, in the mandatory use phase, only the web-based eAF will be accepted. This final stage will be implemented after a transition period that will be officially announced.
  • EMA also reminds that any technical incident related to the use of the eAF must be reported through the  EMA ServiceDesk – Incident channel , while requests for improvements, recommendations or general inquiries must be made through the 
    EMA ServiceDesk – Request service .

Source: AEMPS

European Commission
29 July 2025
Updates to the performance of EU Pharmacovigilance activities

On 22 July 2025, Commission Implementing Regulation (EU) 2025/1466 was adopted amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council.

This Regulation shall enter into force on the twentieth day (11 August 2025) following that of its publication in the Official Journal of the European Union. It shall apply from 12 February 2026.

The Regulation will introduce some new compliance expectations and requirements for applicants and marketing authorisation holders. Further details is available in the Bioslice blog post of 29 July by Alexander Roussanov et al titled Updates to the EU Pharmacovigilance Rules: Key Takeaways for Marketing Authorisation Holders.

EMA and Heads of Medicines Agencies (HMA)
24 July 2025
Pilot on scientific advice on medicine repurposing

EMA and the Heads of Medicines Agencies have concluded their pilot project (which ran between October 2021 and December 2024) supporting the repurposing of authorised medicines for new therapeutic uses.

  • A report is now available on the pilot which provided tailored scientific advice to not-for-profit organisations and academics on repurposing authorised medicines for new indications.
  • The initiative is part of a framework developed jointly with the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) to support not-for-profit organisations and academia in their efforts to bring new therapeutic indications for off-patent medicines to the market.
  • The regulatory guidance and scientific advice provided in this pilot helped them generate robust evidence that meets regulatory standards for these medicines—particularly in areas that may benefit public health.
  • Why it matters is that many authorised medicines hold untapped potential for new uses, but there is often not enough commercial incentives for marketing authorisation holders to develop them.
  • This pilot showed that the gap can be bridged by supporting non-profit and academic developers in advancing patient access to safe, effective, and authorised treatments. 
  • Key takeaways from the report are:
    • EMA and NCAs encourage not-for-profit organisations to seek advice early in a repurposing development programme
    •  EMA will continue to offer a suite of measures to academia, tailored to each specific case
    • This may include:
      • briefings to academia,
      • scientific advice free of charge,
      • facilitating discussions between regulators, academia and pharmaceutical industry
  • The Commission proposals for the reform of the pharmaceutical legislation include measures to facilitate and encourage repurposing of off-patent medicines for new therapeutic uses, with a specific incentive and a dedicated EMA support scheme for SMEs and not-for-profit developers
  • The new pharma legislation will introduce new support measures to boost repurposing initiatives.

Further information is available on the website of the Spanish Agency, AEMPS.

Source: EMA

USA
Canada
10 September 2025
Requirement for a Third party authorisation form

A third party authorisation form is now required within the initial/first transaction of each regulatory activity, when the regulatory contact for an activity, is a third party acting on behalf of the manufacturer/sponsor.

Source: Health Canada

1 August 2025
Guidance on nitrosamine impurities in medicines

The guidance with the above title was last updated on 1 August 2025. You can view it here.

In this guidance document, changes from the previous version are identified with the descriptors “new” or “updated” (as applicable). Information on a similar theme is grouped together under general headings (for example, General, Safety and Quality).

Source: Health Canada

4 September 2025
FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch

The FDA released today, 89 previously unpublished CRLs issued from 2024 to the present associated with pending or withdrawn applications.

  • Each of these CRLs detail specific safety and effectiveness deficiencies identified by the FDA as preventing the application from receiving approval. 
  • Going forward, the agency will promptly release newly issued CRLs, and when approving applications will release all CRLs associated with that application.
  • The agency will also publish batches of previously issued CRLs associated with withdrawn or abandoned applications.
  • All CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names. 
  • Decision letters are accessible to the public as a centralized dataset at openFDA.

Source: FDA

29 August 2025
eCTD Submission Standards updates

FDA has published updates for the following:

Source: FDA

28 August 2025
CMC Development and Readiness Pilot (CDRP) Program

 FDA announced it will begin accepting requests on 1 October 2025, to participate in year four of the CDRP program

  • On October 31, 2022, FDA first announced the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program for CBER and CDER regulated products.
  • CBER and CDER are continuing to conduct the CDRP to facilitate CMC development of selected products under investigational new drug (IND) applications with expedited clinical development timeframes to help patients get access to these products sooner.
  • Sponsors of INDs with accelerated clinical development timelines are invited to apply to the CDRP. 
  • On 1 October 2025, FDA will begin accepting requests from sponsors who wish to participate in year four of the CDRP.

Further information is available at the link below.

Source: FDA

19 August 2025
CDER Nitrosamine Impurity Acceptable Intake Limits

This page was last updated on 18 August 2025.

The latest update (s) appear to be in Table 3: Recommended Interim AI Limits* for Certain Nitrosamine Impurities** for Approved or Currently Marketed Products

Source: FDA

22 July 2025
Commissioner’s National Priority Voucher (CNPV) Pilot Program

The FDA is announcing the opportunity for a limited number of drug and biologic developers (“companies”) to participate in the FDA Commissioner’s National Priority Voucher (CNPV) pilot program.

  • The CNPV pilot program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.
  • Announced in June 2025, this innovative program uses a collaborative tumor board (multidisciplinary team meeting) style review process to accelerate approvals for companies aligned with critical U.S. national health priorities.
  • Companies selected for the program will be issued a voucher entitling the company to benefits including enhanced communications and rolling review to allow for a shortened review time.
  • The CNPV pilot program reflects the FDA’s broader commitment to create more efficient approval processes and modernize regulatory frameworks for greater agility to meet emerging public health needs.
  • Key Program Benefits are:
    • Faster review times (10-12 months vs. 1-2 months)
    • Enhanced communication throughout the review process
    • Multidisciplinary team-based evaluation
    • Potential for accelerated approval if applicable requirements are met
    • Maintains FDA’s rigorous safety and efficacy standards

Further information is available at the link below.

Source: FDA

10 July 2025
FDA Embraces Radical Transparency by Publishing Complete Response Letters

The FDA published more than 200 decision letters, known as complete response letters (CRLs).

  • The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024, marking a significant step in the Agency’s broader initiatives to modernize and increase transparency.
  • By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved
  • CRLs are issued directly to product sponsors when the FDA completes its review cycle and determines that it cannot grant an approval of an application in its current form.
  • The FDA issues CRLs for various reasons, most related to safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues. These deficiencies are detailed in the letter and may also include recommendations for addressing them.

Further reading:

FDA Release of Complete Response Letters Raises Confidentiality, Disclosure Questions But Offers Insights for Development, Sidley, 11 July 2025.

Source: FDA

Brazil
28 August 2025
Anvisa strengthens regulatory cooperation with Cofepris including signing of a Memorandum of understanding (MoU)

On 27 & 28 August, a meeting took place between officials from Anvisa and Cofepris (Mexico).

  • One of the results of the meeying was the signing of a new Memorandum of Understanding between Anvisa and Cofepris, which expands cooperation in strategic issues such as regulatory trust (reliance) and exchange of information.
  • In recent years, the two regulatory authorities have advanced regulatory confidence initiatives.
  • As a result of these initiatives, Cofepris recognized Anvisa as the Reference Regulatory Authority for: expedited sanitary registration of medical devices; and recognition of the Certificates of Good Manufacturing Practices (CBPF) of drugs, medicines and medical devices issued by Anvisa.
  • In turn, Anvisa recognized Cofepris as a Equivalent Foreign Regulatory Authority for the Certification of Good Manufacturing Practices (CBPF) of medicines.
  • These measures reduce costs, facilitate bilateral trade and extend population access to modern and innovative technologies.
  • The signing of the new Memorandum of Understanding also strengthens cooperation and is another important step by Anvisa to strengthen regional integration and international regulatory trust.

Source: Anvisa

6 August 2025 (updated on 25 August 2025)
Anvisa changes to the validity of the renewal of Certificate of Good Practices

As of June of this year, Anvisa has implemented a change in the first day of validity of the renewal of the Certificate of Good Practices (CBP).

  • In the new system, when a renewal is published, its first day of validity will be equal to the last day of the validity of the current certification (and no longer from the date of publication).
  • This means that the certifications will be valid (two or four years, depending on the type), without reduction or increase of days of validity, according to the day of the publication of the resolution.
  • For example, if a certification petition is due on 31 December 2025 and had its renewal published on 31 October 2025, then the first day of validity of the renewal will be 31 December 2025 and not 31 October, 2025.
  • In the Anvisa Consultations Portal, certification renewals published before the expiration of the validity of the current certification will not be shown until they are in force, even if they have already been published in the Official Gazette of the Union (e.g. in the previous example, it will only be possible to consult the renewal from December 31, 2025).

Follow up on 25 August 2025

In line with the information above, on 25 August, Anvisa published renewals of Good Manufacturing Practice Certificates (CBPFs) of health products, with changes in the form of counting the first day of validity of the renewed certificate.

  • Resolutions 3.208, 3.209 and 3.213, of August 21, 2025, already consider as the first day of validity of the renewed certifications, the maturity date of the current certification, and no longer the date of publication of the renewal application.
  • In addition, for each petition, the new date of validity of the certification was included in the annex of the resolution.

Source: Anvisa; Anvisa

7 August 2025
Anvisa and Egyptian Drug Authority Sign Memorandum of Understanding

Anvisa and the Egyptian Drug Authority (EDA) signed a Memorandum of Understanding (MoU) with the aim of strengthening cooperation between the two institutions in the field of health regulation.

  • The signing of the MoU reinforces the two authorities’ commitment to exchanging information and experiences, as well as promoting good regulatory practices in areas such as medicines and medical devices.
  • Anvisa and EDA already work together in relevant international forums, such as the ICH and the IMDRF, actively contributing to the harmonization of standards and the strengthening of global health regulation.
  • The partnership also paves the way for future joint actions and collaborative projects focused on technical development and public health protection, with benefits for the regulatory systems of Brazil and Egypt.

Source: Anvisa

6 August 2025
SCMED releases list of drug presentations that will be inactivated in Sammed

The Executive Secretariat of the Drug Market Regulation Chamber (SCMED) released the list of drug presentations that will be inactivated in the Drug Market Monitoring System (Sammed), for not having submitted commercialization data in the last five semesters (2nd semester/2022, 2023 and 2024).

The CMED 3/2025 Ordinance was published on Tuesday 5 August 2025 and comes into force on 1 September 2025.

Source: Anvisa

Mexico
21 July 2025
Mexico to recognize medicines evaluations issued by Reference Regulatory Authorities (RRAs) and decisions of RRAs on medical devices for the purpose of Good Manufacturing Practices Certifications. 

COFEPRIS reports that following an agreement with the pharmaceutical and medical device sectors, the Agreement issuing the General Guidelines for the application of the abbreviated regulatory route for the granting of health registrations for health supplies in which the requested requirements, tests and evaluation procedures issued by reference regulatory authorities and the prequalification program of the World Health Organization (WHO) are recognized as equivalent was published in the Official Gazette of the Federation (DOF).

  • These guidelines indicate that for medicines, COFEPRIS will recognize evaluations issued by Reference Regulatory Authorities (RRAs) i.e. those of countries that are founding members and permanent regulators of the ICH as well as authorities included in the list of WHO Listed Authorities (WLAs).
  • With reference to the recognition of medical devices, this commission will recognize the decisions of the RRAs of member countries of the IMDRF as well as those authorities that are full members of the MDSAP, for the purposes of Good Manufacturing Practices Certifications. 
  • Likewise, this regulatory instrument, published on 18 July 2025, will allow for expanded timely access to health supplies from abroad. Its design integrates principles of Good Regulatory Practices, emphasizing reliance i.e. the recognition of decisions issued by leading regulatory authorities, according to the WHO.
  • Among the application types that may be recognized under this scheme are
    • new molecules, pursuant to Article 2, Section XV, of the Health Inputs Regulation
    • generic drugs
    • innovative biotechnological products
    • biocomparable biotechnological products
    • biological products and vaccines
    • medical devices.

Source: Anvisa

Australia
22 September 2025
TGA GMP Clearance: backlog reduction strategy recap and next steps

On 1 July, the TGA introduced the GMP Clearance backlog reduction strategy which comprised of:

  • The automatic extension of existing Mutual Recognition Agreement (MRA) and non-sterile Active Pharmaceutical Ingredient (API) CV GMP clearances that were due to expire between 1 July 2025 and 30 June 2027
  • Commencing abbreviated evaluation of manufacturing sites performing certain lower risk activities
  • Ending GMP clearance regulatory flexibilities introduced during COVID-19 pandemic, specifically the GMP Clearance Questionnaire.

All strategies have now been implemented, and the backlog is reducing at the expected rate.

The GMP Clearance Sponsor Information Dashboard (SID) has also been refreshed with more data and insights. Ongoing progress reporting will be communicated on this page.

Further information is available at the link below.

Source: TGA

9 September 2025
Adoption of International Scientific Guidelines in Australia – R02/2024

TGA has adopted the following three international scientific guidelines:

  1. ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
  2. Guideline on quality documentation for medicinal products when used with a medical device.
  3. Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems.

Source: TGA

27 August 2025
Planned update to manufacturing principles for medicines and APIs

Australia’s current Manufacturing Principles for the manufacture of medicines and active pharmaceutical ingredients and sunscreens are the PIC/S Guide to Good Manufacturing Practice (GMP) – 1 February 2022, PE009-16, except for its Annexes 4, 5, and 14. This version of the PIC/S Guide was adopted on 3 June 2024.

  • TGA is moving to a more recent version and will be adopting the PIC/S Guide to GMP – 25 August 2023, PE009-17, except for Annexes 4, 5 and 14 on 1 September 2025. 
  • The changes in version 17 relate only to Annex which has has been amended and contains information and requirements related to the manufacture of sterile medicinal products.
  • From 1 September 2025 the PIC/S Guide to GMP – 25 August 2023, PE009-17 will apply to the manufacture of medicines and active pharmaceutical ingredients and sunscreens, unless exempt under provisions in the Therapeutic Goods Act 1989 (the Act). It is also the date from which point GMP inspectors will use the new Guide to GMP during inspections.
  • Compliance with the basic requirements of the PIC/S Guide to GMP – 25 August 2023, PE009-17 will be expected from the date of adoption. 
  • TGA does not expect manufacturers of sterile medicines, to have data immediately available to meet some of the new requirements. As a result, a phased approach is being taken to assessing compliance with these items during TGAs on-site inspections. 
  • TGA will update existing guidance on the interpretation on the PIC/S Guide to GMP, to reflect changes introduced by the adoption of PE00-17 – 25 August 2023.
  • Manufacturers are encouraged to review the PIC/S Guide to GMP – 25 August 2023, PE009-17 and ensure you are familiar with the requirements relevant to your manufacturing operations.
  • Hear you can view PE 009-17 (Part I) Aug 2023 and PE 009-17 (Part II) (Aug 2023). The Guide is divided into two parts with 20 annexes.

Source: TGA

18 August 2025

TGA has updated the GMP Clearance Sponsor Information Dashboard (SID) to provide greater transparency on its data and its progress in reducing the backlog of CV applications. 

The dashboard has changed from monthly ‘point in time’ reporting to include:

  • Progress and narration on the backlog reduction
  • Trending data for the past 12 months across all CV streams
  • Visual representation of GMP Clearance application status and queues
  • Additional processing timeframe data for different percentiles, not just the 90th percentile
  • 6 month rolling snapshot of application quality (the number of incomplete applications or requests for information required)

The data will be updated every 4 to 6 weeks to ensure it remains current.

Source: TGA

10 July 2025
GMP Clearance: backlog reduction strategy progress update

TGA has extended all Mutual Recognition Agreement (MRA) and Non-Sterile Active Pharmaceutical Ingredient (API) Compliance Verification (CV) GMP Clearances, which were expiring between 1 July 2025 and 30 June 2027 for a period of 2 years.

  • In total 6258 extensions have been processed and individual notifications were not sent for each extension. 
  • Sponsors can view their GMP Clearance expiry dates in the TGA eBusiness Service portal.
  • If you believe a GMP Clearance should have been extended but is not updated on your portal, contact the TGA at GMPclearance@health.gov.au
  • TGA will now start processing corresponding applications in its lodgement queues as outlined in its GMP Clearance backlog reduction strategy.
  • If more recent evidence is available, please provide this information before TGA evaluates the corresponding applications, otherwise, they will be processed using the information currently on file.
  • If you have applications that are no longer required, please consider withdrawing them from the system. This will help TGA identify applications that can be closed more easily.
  • A webinar was held on 19 June 2025 providing further information about the backlog reduction strategy. The recording is now available.

Source: TGA

GMP Clearance – Backlog reduction strategy

From 1 July 2025, the TGA is introducing the following temporary risk-based strategies for GMP Clearance:

  • All existing MRA and non-sterile API CV GMP Clearances due to expire between 1 July 2025 and 30 June 2027 will be extended automatically for a period of 2 years beyond their current expiration date
  • Abbreviated evaluation of manufacturing sites performing certain lower risk activities. These may include the following types of manufacturers:
    • testing laboratories
    • secondary packaging and storage sites
    • cell banking facilities
  • Ending GMP clearance regulatory flexibilities introduced during COVID-19 pandemic, specifically the GMP Clearance Questionnaire i.e. for CV applications submitted from 1 July 2025, the TGA will return to pre-pandemic business rules and no longer accept evidence from inspections conducted more than 3 years ago, including supporting documentation such as the GMP Clearance questionnaire.

More detailed information is available at the link below.

The TGA expects that these initiatives will build upon the progress that has already been made in reducing the number of applications that it has on hand and improve processing times.

Source: TGA

Japan
29 September 2025
Early Consideration on Handling of Japanese Data for Confirmation of Comparability of Biosimilars to the Original Biopharmaceuticals

The PMDA has published a provisional translation of a document with the above title. You can view it here. It would appear that the document applies to generic drugs, For generic drugs, Japanese data are not mandatory in evaluating bioequivalence.

Source: PMDA

5 September 2025
GMP / GCTP Annual Report

PMDA has published GMP / GCTP Annual Report 2024. You can view it here and an accompanying list of identified deficiencies can be viewed here.

Source: PMDA

Malaysia
22 September 2025
Guidance Document And Guidelines For Registration Of Cell And Gene Therapy Products (CGTPs) In Malaysia

The second edition (September 2025) of the above guidance has now been published. Ypu can view it at the link below.

Source: NPRA

Directive on updating Good Laboratory Practice (GLP) requirements and implementing study-specific GLP inspections on overseas study facilities for non-clinical safety studies for the purpose of registration of New Chemical Entity (NCE) products, biologics and natural products with therapeutic claims

The Directive with the above title has been published. You can view it at the link below.

Source: NPRA

22 July 2025
Drug Registration Guidance Document (DRGD) Third Edition, Tenth Revision July 2025

This document outlines an official directive from the NPRA.

  • It introduces the Drug Registration Guidance Document (DRGD) Third Edition, Tenth Revision July 2025, which serves as an updated guideline for the registration of pharmaceutical products within Malaysia.
  • This directive, effective July 31, 2025, builds upon previous iterations of the DRGD dating back to 2004, providing regulatory instructions for product applicants and holders to ensure compliance with the Control of Drugs and Cosmetics Regulations 1984.

Source: NPRA

14 July 2025

The following documents have been published

1. Directive Concerning the Expansion of the Scope of Products Implementing Electronic Labeling (E-Labelling) to the Category of Generic-Non-Pharmaceutical Scheduled Products (Over-The-Counter Products, OTC)

This document (in the local language) outlines a directive from the Drug Control Authority (DCA) regarding the expansion of electronic labeling (e-labeling) for certain products.

  • Specifically, it extends the voluntary e-labeling implementation to include Over-the-Counter (OTC) generic products that are not scheduled poisons, effective from August 1, 2025, through December 31, 2026.
  • This initiative aims to enhance accessibility, searchability, and quick information exchange while promoting environmental friendliness.
  • This new directive builds upon a previous one issued in April 2023, which initially covered biologic products, new drug products, and generic drugs containing scheduled poisons.

2. Guideline on Electronic Labelling (e-Labelling) for Pharmaceutical Products in Malaysia, 2nd Edition (August 2025) (in English) – This document serves as a guide for the implementation of voluntary e-labelling. The document shall be reviewed when necessary.

3. Frequently Asked Questions (FAQ) e-labelling – Revised 1 August 2025 (in English)

It is unclear what changes have been made to documents 2 and 3 above.

Source: NPRA

9 July 2025
Surveillance and complaints section highlights of 2024

The NPRA continues to monitor registered products in the local market to ensure the compliance of regulatory requirements in terms of quality, safety, and efficacy.

This summary highlights key activities and programs undertaken by the Surveillance and Complaints Section (SVA), Centre for Compliance and Quality Control (CCQC), NPRA in 2024, focusing on four primary activities as listed below:

  1. Sampling of registered products
  2. Handling of complaint reports on the quality of registered products
  3. Handling of quality reports from Product Registration Holders (PRH)
  4. Handling of ASEAN post-marketing alert system (PMAS) rapid alerts

Source: NPRA

7 July 2025
Circular Regarding the Use of QR Codes by Product Registration Holders (PRH) for the Purpose of Distributing Additional Risk Minimisation Materials (aRMM) to Healthcare Professionals and Patients

You can download the circular (in the local language) here.

QR Code Usage Guide for Additional Risk Minimization Materials (aRMM)

You can download the circular (in the local language) here.

Source: NPRA

The Philippines
10 September 2025
Temporary Suspension for Sixty (60) Working Days of the Implementation of Administrative Order No. 2024-0016 entitled, Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration”

The Department Circular (DC) No. 2025-0240, entitled “Temporary Suspension for Sixty (60) Working Days of the Implementation of Administrative Order (AO) No. 2024-0016 entitled, Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration”, issued on 10 June 2025, temporarily suspended the implementation of AO No. 2024-0016 for a period of sixty (60) working days.

  • The temporary suspension aimed to allow the Food and Drug Administration to conduct consultations and an internal review of the fees structure to ensure the effective implementation of AO No. 2024-0016.
  • Considering the ongoing review and succeeding consultations to address the concerns raised by various stakeholders, the suspension of the implementation of AO 2024-0016 as provided under DC No. 2025-0240 is hereby extended for an additional sixty (60) working days which shall commence after the initial sixty (60) working days temporary suspension period prescribed therein.
  • This extension is intended to allow the FDA sufficient time to finalize the necessary adjustments to internal processes and ensure the full and effective implementation of AO No. 2024-0016.
  • Accordingly, all provisions stipulated under DC No. 2025-0240 shall remain in effect.
  • This Department Circular shall take effect immediately.

Source: FDA, The Philippines

Pakistan
29 August 2025
Submission of Required Details for Implementation of 2-D Barcode & Serialization by 1st September 2025

DRAP is in the process of implementing 2-D Barcodes along with serialization for pharmaceutical products.

In this regard, the pharmaceutical industry is hereby directed to provide the required details in the attached form no later than 1st September, 2025.

Source: DRAP

26 August 2025
DRAP to adopt Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines

In the Drugs (Licensing, Registering, and Advertising) Rules, 1976, further
amendments as detailed in this notification shall take effect six months after commencement of this notification is made.

Source: DRAP

11 August 2025
Recent Policy Updates and Procedural Guidelines for Drug Registration and Processing

DRAP is dedicated to promote a functional, effiicient, and science-driven regulatory environment.

It has recently put in place, the following changes:

  1. Streamlining The Evaluation and Processing of Form 5F (Common Technical Document) Applications Under S.R.O. 713(I)/ 2018.
    • At its meeting of 4th June 2025, it has formally approved revised procedures for the submission of registration dossiers for liquid injectable products that possess the same strength per unit but are presented in varying fill volumes.
  2. Submission of Summary of Product Characteristics (SmPC) And Patient Information Leaflet (PIL) Along with CTD Dossier (Form 5-F).​
    • It has been decided that the submission of Summary of Product Characteristics (SmPC) and Patient Information Leaflet shall be made mandatory for all drug registration applications.
    • These documents shall form an integral part of the Form-SF (Common Technical Document) dossier, under Section 1.5.14, in accordance with DRAp,s already published guidance document available on DRAP website (https://encr.p HtCCw).
    • For imported finished pharmaceutical and biological products, this his requirement shall be implemented for applications submitted on or after 15th September, 2025
    • For locally manufactured pharmaceutical and biological products, this requirement shall be implemented for applications submitted on or after l5.h October, 202S.
  3. Borrowing of APIs for Performing Product Development, R & D and Stability Testing Registration Board Decision Thereof.
    • Effective immediately, the borrowing of APIs on a loan basis will be exclusively permitted only to holders of new Drug Manufacturing Licenses (DMLs), and this facility will be limited to a maximum of ten (10) molecules per manufacturing license section.
  4. Quality-Based Incentivisation of Applications for Local Manufacturers
    • ​The following eligibility criteria for drug registration applications to qualify for quality-based priority review:
      • i) Comprehensive Dossier Submission: Submission of a complete Form 5F dossier (CTD) without availing any data exemptions specified in current guidance documents.
      • ii) Robust Drug Product Stability Data: Inclusion of comprehensive drug product stability data, encompassing detailed impurity profiles and and./or degradation studies, prepared strictly in accordance with applicable pharmacopoeial requirements or established intemational guidelines.
      • iii. Inclusion of Bioequivalence Studies: Dossiers that incorporate duly conducted and acceptable bioequivalence studies.

The full details of these changes can be viewed at the link below.

Source: DRAP

5 August 2025
Revised Regulatory Fees for Therapeutic Goods

A revised table of fees has been published.

Source: DRAP

23 July 2025
Requirement for the inclusion of bioequivalence studies in a registration application

Phase-I for the inclusion of bioequivalence studies in registration applications from the date of issuance of this notification and will mandate the submission of Bioequivalence studies for the drug substances provided in Annexure-I (see document). The Registration Board will periodically review the list in subsequent phases, as and when required, based on the experience gained, evolving regulatory landscape and in adherence to ICH/WHO guidelines.

Source: DRAP

South Korea
13 August 2025
MFDS Fully Listed for All Functions as a WHO Listed Authority(WLA)

The MFDS announced that it has been officially listed as a WHO Listed Authority (WLA) for all regulatory functions.

This follows its initial listing in October 2023, confirming recognized MFDS’s regulatory excellence in medicine and vaccine through additional assessment procedures in marketing authorization and clinical trial elements within regulatory inspection.

Full-scale realization of expected benefits include export expansion through favorable conditions in International Procurement.

Source: MFDS

Singapore
13 August 2025
HSA Signs Memorandum Of Understanding With Hong Kong DoH To Enhance Healthcare Regulatory Cooperation

The HSA and the DoH, Hong Kong Special Administrative Region (HKSAR) signed a Memorandum of Understanding (MOU) for cooperation in healthcare regulatory matters pertaining to health products, on 13 August 2025.

This MOU marks an important milestone in strengthening ties between the two regulatory authorities.

  • The MOU encompasses technical cooperation and mutual exchange of information, best practices and expertise pertaining to healthcare regulatory matters across a broad spectrum of health products, including pharmaceuticals, medical devices and advanced therapy products.
  • The agreement also facilitates the sharing of regulatory information and enforcement approaches towards tobacco products and vaping devices.
  • To support these objectives, the MOU enables exchange of regulatory experts and staff, participation in meetings and scientific conferences, as well as collaboration in training courses and joint projects.

Source: HSA

30 July 2025
Regulatory Updates for Therapeutic Product Registration

As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in its regulatory requirements and processes, the TPB Health Products Regulation Group, has provided a tabulated update to industry on the following topics:

  • Enhancement of application checklists for NDA, GDA and MAV submission
  • Clarification on prerequisite documents for acceptance of application for screening
  • Updated acceptable proof of GMP compliance for drug product manufacturing sites
  • Introduction of a new online form for DMF submission
  • Streamlining of dossier requirements for MAV-1 verification evaluation route
  • Enhancement of criteria for forensic classification of TPs (POM/P/GSL) 
  • Other revisions

These changes will take effect from 30 Jul 2025. Please refer to the updated guidance documents for detailed information.

Status updates on eCTD implementation

TPB conducted a virtual training for industry and interested stakeholders on HSA eCTD portal on 28 May 2025.

  • The training included demo sessions on the workflow and processes for eCTD submission via the portal.
  • The video recording and presentation slides with FAQs are available for download here. 

Source: HSA

India
7 August 2025
Grant of WHO GMP COPP through ONDLS Portal reg

Following representations received from stakeholders and in support of industry interests, the deadline for paper submissions for WHO-GMP (COPP) applications has been extended by a month up to 15 August 2025. After this date, no paper submissions will be accepted.

Source: CDSCO

17 July 2025
The subject expert committees expert (SEC) document

CDSCO has published version 1.0 of the above document.

SEC experts:

  • examine and advice Drugs Controller General (India) (DGCI) on the proposals related to new drugs, clinical trials, new Investigational medical devices for regulatory approvals in the country.
  • evaluate animal study, pre-clinical & clinical data along with the study protocol to undertake clinical trials to determine safety, efficacy and rationality of new drugs, Investigational medical devices.

Source: CDSCO

9 July 2025
Clinical Trials applications (Phases I, II and III) for cell and gene therapies via the the SUGAM online portal

In order to streamline the regulatory submission and assessment procedure, CDSCO has made a provision for filing Clinical Trials Applications for cell and gene therapy products (CGTP) via SUGAM online portal.

Applications for such applications may now be submitted via the SUGAM portal. Offline submissions for CGTP applications will not be accepted for processing by CDSCO after 10 July 2025.

Source: CDSCO

Switzerland
19 September 2025
Swissdamed technical documents

The following are available in the technical documentation on the Swissmedic website.

Source: Swissmedic

8 August 2025
EU Commission Implementing Regulation on instructions for use in electronic form – Implementation in Switzerland

With the the adoption on 25 June 2025 of EU Commission Implementing Regulation (EU) 2025/1234, the regulations governing the provision of electronic instructions for use have been extended.

  • Swissmedic has adopted these requirements with immediate effect, allowing electronic instructions for use intended for professional users in Switzerland too.
  • Where devices are intended for professional users, the permissible scope for electronic instructions for use has been extended to all medical devices and their accessories as well as to products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (EU MDR) and legacy devices.
  • The instructions for use of devices intended for use by lay persons must continue to be provided in paper form.
  • When registering devices, manufacturers must provide to Eudamed’s Unique Device Identifier (UDI) database the internet address under which the electronic instructions for use are accessible.
  • Regulation (EU) 2025/1234 has repealed Regulation (EU) 207/2012 on electronic instructions for use of medical devices, to which reference is made in Annex I, Chapter III point 23.1 EU MDR.
  • The old regulation was in force from 25 May 2024 and, until it was fully repealed by Commission Implementing Regulation (EU) 2025/1234, applied solely to devices that fulfil the requirements of Article 120 para. 3 EU MDR. These devices are referred to as “legacy devices”.

Source: Swissmedic

European Commission
12 September 2025
Update – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746

Version 4 (September 2025) of the above manual has been published. You can view/download it here.

Source: European Commission

UK
5 September 2025
Guidance updated: Medical devices – post-market surveillance

The MHRA has published the document, Medical devices: Standardised format for the post market surveillance report. You can view it here.

  • This document is intended to guide manufacturers on what data to include within a Post market surveillance report (PMSR).
  • It is not mandatory to include sections which do not apply, and data may be displayed in an alternative form if appropriate.
  • If a manufacturer decides that specific sections or datasets are not required, they should document the justification in the PMSR.
  • The PMSR should be a stand-alone document that can be assessed independently from the supporting documentation.

Source: MHRA

2 September 2025
Guidance updated: Make a payment to MHRA

This guidance has been updated for clarification that Device Registration and Certificates of Free Sale for medical device fees must be made only though the Device Online Registration system (DORS).

Source: MHRA

7 August 2025
Updated: User Reference Guide – MORE Incident Submissions

The above reference guide has been updated to version 5 of July 2025.

The PSR submission process has been updated to reflect the resumption of uploads via the MORE portal. The SAE section has been revised to include additional guidance on Quarterly Safety Reports (QSRs).

Source: MHRA

5 August 2025
Guidance updated : Clinical investigations for medical devices

The wording in the Payment for a clinical investigation section has been revised to remove reference to ‘amendments to a clinical investigation’.

Source: MHRA

31 July 2025
MHRA outlines intent to speed up patient access to innovative medical devices

The MHRA is setting out its intention (see statement of policy intent) to enable earlier access to innovative medical devices that address unmet clinical needs within the NHS.

  • This Statement of Policy Intent sets out the MHRAs initial thinking on an Early Access service which will be developed further over the coming months.
  • As part of this intention, capability will be invested to establish a new Early Access service to provide time-limited, conditional access to promising technologies ahead of full regulatory approval, where there is clear clinical need and supporting evidence of benefit for patients.
  • The Early Access service will:
    • Offer conditional market access for innovative devices that address clearly defined unmet clinical needs from the NHS or that have the potential to significantly improve patient outcomes.
    • Offer a bridging scheme to maintain patient access to devices where the clinical investigation has ended and the manufacturer is still awaiting regulatory approval.
    • Focus initially on innovative diagnostic devices, particularly those supporting the NHS’s most urgent needs and financial sustainability in the NHS.
  • Designed to support innovators, including small and medium-sized enterprises (SMEs) , the Early Access service aims to help bring safe and effective medical devices to patients more quickly.
  • It takes on learnings from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP) and is shaped by stakeholder engagement with key sector representatives.
  • The intent is to turn the UCNA tool into a business-as-usual Early Access service available to innovators outside of an innovation pathway such as IDAP.
  • This will enable more patients to benefit from earlier access to innovative technologies in areas of unmet clinical need.
  • This will be delivered through risk-proportionate regulation and ongoing support for innovators, reinforcing the UK’s role as a global leader in innovative technology.
  • The MHRA has identified three strategic opportunities to support this direction:
    • Supporting access for patients: Transforming regulatory assessments into streamlined, risk-proportionate services, to reduce time to patient access for controlled populations.
    • Widening innovator access to early access services: This approach especially supports early-stage and SME innovators by making a key service for early access more accessible, making Great Britain (GB) an attractive environment for innovators to start, grow, scale and invest.
    • Evidence generation through real-world data: Enabling earlier market access, supported by real-world evidence generation to bridge the gap between research (i.e. clinical investigations) and scalable product development, where it may be challenging to navigate, while maintaining patient safety and robust standards.
  • The initiative sits within a broader programme of regulatory reform, including strengthened post-market surveillance and increased international collaboration.
  • The MHRA will continue to work with industry, clinicians, NHS leaders and other partners to shape the pathway and support growth across the UK MedTech sector.

Source: MHRA

22 July 2025
MHRA announces proposals to improve access to world’s best medical devices for patients and to boost economic growth in Britain’s med tech sector

The MHRA has announced new routes to improve patient access to the world’s best medical devices and boost growth.

It is taking major steps to improve access for UK patients to the latest medical technologies from trusted regulators in Australia, Canada, and the USA – while boosting growth in Britain’s med tech sector.

As set out in its consultation response, the MHRA will:

  • Introduce international reliance routes for faster access to safe, effective devices already approved by other trusted regulators overseas
  • Consult on the indefinite recognition of CE-marked devices later this year
  • Focus the domestic UKCA route on first-in-market innovation, including AI as a medical device
  • Support the removal of physical UKCA markings once unique device identification (UDI) is in place
  • A more risk proportionate route to market for Class B in vitro diagnostic devices
  • These changes will reduce regulatory duplication, support innovation, and strengthen the UK’s position as a global med tech leader.

Further information is available in this blog post.

Source: MHRA

16 July 2025
Guidance updated: Register medical devices to place on the market

This guidance has been updated to reflect the Statutory Registration fee increase to £261 from 16 July 2025.

Source: MHRA

Guidance updated: Clinical investigations for medical devices

The ‘Amendments’ and ‘Fees’ sections of this guidance have been updated to reflect new fees applicable from 16 July 2025.

Source: MHRA

10 July 2025
Government to align with European specifications on high risk in vitro diagnostic devices to reduce regulatory burden 

The Government has announced its intention to amend the Medical Devices Regulations 2002 for Great Britain to incorporate EU Common Specifications for high-risk in vitro diagnostic (IVD) devices and to repeal regulations on Coronavirus Test Device Approvals (CTDA).  

  • Respondents overwhelmingly supported a proposal to repeal the current CTDA process for COVID-19 devices and to replace current requirements with Common Specifications. In the interim, an accelerated CTDA process will be introduced for COVID-19 devices that have CE marking under the European IVD regulations (EU IVDR) and meet Common Specification requirements. 
  • The Common Specifications will also enhance performance standards for IVD devices related to infectious diseases including Hepatitis B, C and D, HIV and Syphilis, as well as devices for blood grouping and tissue typing. These diagnostic tools are critical for effective patient care and public health management. 
  • The move aims to ensure these vital IVD devices, which test samples from the human body to monitor health or manage disease, meet high standards of performance backed by robust clinical evidence. 
  • These new specifications will be introduced in regulations expected to be published later this year as part of the Government’s broader programme of medical devices regulatory reform, which supports the NHS transformation. 
  • The specifications will establish standards for high-risk diagnostic tests while creating consistency with European regulations
  • The changes reinforce the Government’s commitment to reduce regulatory burden and balance robust patient safety measures with support for innovation in the medical technology sector. 

Source: MHRA

2 July 2025
Guidance: Medical devices: Standardised format for the periodic safety update report

This document concerns Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).

  • It is intended to guide manufacturers on what data to include within a periodic safety update report (PSUR).
  • It is not mandatory to include sections which do not apply, and data may be displayed in an alternative form if appropriate.

Source: MHRA

Australia
29 August 2025
TGA on compliance of AI and software-based medical devices

The TGA is stepping up its efforts to make sure that software-based medical devices meet Australia’s regulatory requirements. This includes those using artificial intelligence (AI).

It is already working closely with industry to:

  • encourage voluntary compliance
  • provide clear and consistent guidance
  • respond to complaints and reports of non-compliance
  • identify and address unlawful advertising and supply.

TGAs current focus includes reviewing AI digital scribes, some of which are introducing more advanced features such as diagnostic and treatment suggestions. See further information on AI scribes below.

Source: TGA

14 August 2025
New information on digital scribes

TGA has published information to clarify when digital scribes – also referred to as AI scribes or ambient scribes – are regulated as medical devices in Australia.

This information outlines its regulatory approach to digital scribes that meet the definition of a medical device and provides links to further resources regarding:

  • key responsibilities for safe and appropriate use, including informed consent
  • consumer rights relating to privacy, personal information and the use of digital scribes in care
  • the need to review software updates that could change how the product functions, and
  • how to report safety concerns or suspected non-compliance.

Source: TGA

30 July 2025
TGA report: Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI)

The TGA has published its Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) report. You can access a summary of responses to the public consultation on the TGA Consultation Hub.

Source: TGA

Singapore and Malaysia
22 August 2025
Malaysia and Singapore Sign Memorandum of Understanding (MoU) and Launch Medical Device Regulatory Reliance Pilot to Fast Track Medical Device Market Access

The (MDA of Malaysia and the HSA of Singapore signed a MoU to deepen regulatory cooperation and officially launched a 6-month pilot of the Medical Device Regulatory Reliance Programme as part of the MOU.

  • This strategic MoU cements a new era of regulatory convergence and industry collaboration between Malaysia and Singapore.
  • Running from 1 September 2025 to 28 February 2026, the pilot programme will streamline the registration of Class B, C and D medical devices, delivering the following:
    • Faster approvals through reliance on each other’s regulatory assessment and approvals;
    • Reduced duplications of reviews, cutting costs and time-to-market; and
    • Earlier patient access to safe, innovative and high quality medical technologies.
  • Through this pilot programme, both regulators will work closely to:
    • test streamlined pathways,
    • refine and establish clear standard operating procedures for the reliance pathway,
    • validate shortened processing timelines and
    • gather stakeholders’ feedback, so that an effective and scalable regulatory reliance programme can be built after the pilot.
  • Medical Device Registration Certificate Holders participating in the pilot can expect reduced review times for medical device registration in both countries.
    • In Malaysia: Devices registered with HSA may undergo a verification route (abridged review pathway) through MDA’s Conformity Assessment Body (CAB).
    • The review is expected to take 30 working days, compared to 60 working days under the full conformity assessment route. The device will then be registered within 30 working days.
    • In Singapore: Devices registered with MDA will benefit from an abridged review pathway, achieving up to 30% shorter review times across all Class B to D medical devices.

Source: HSA

Singapore
21 July 2025
Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS) updated

The Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS) have been updated. the key updates are:

  • Change in document title to “Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS)” to improve online searchability
  • The term “Standalone Medical Mobile Applications” has been replaced with “SaMD” for better international alignment
  • More clarity has been provided on the critera for when an SaMD will be classified as Class B if its functionality falls under rule 10(i) of GN-13
  • Additional criteria (i.e. Output/recommendations of CDSS is solely based on established clinical guidelines) included to determine whether a CDSS is considered a non-MD

The finalised version can be accessed here and is effective effective from 21 July 2025.

Source: HSA

14 July 2025
Updates to GN-21

The Medical Devices Cluster (MDC) has updated GN-21: Guidance on Change Notification for Registered Medical Devices.

The Key Updates to GN-21 are:

  • Expanded the list of changes which do not require Change notification application to be submitted
  • Added Flowchart 2.5 Changes to Machine Learning-enabled Medical Device (MLMD) to provide further clarity on Change Notification routes applicable to changes made to MLMDs
  • Editorial changes to Flowchart 5 Changes to Labelling to provide clarity on labelling changes to indications of use, warnings, precautions and/ or adverse events that will fall under Notifications route.
  • Addition of Change type 6E – Submit UDI data elements for registered devices
  • Removal of marketing history requirement under 6Ai Addition of models
  • Change notification application will not be required for Class A medical devices

The updated version can be accessed here and will be effective from 14 July 2025

Pakistan
19 July 2025
New online MDMC licensing and product registration portal

DRAP has launched anew online MDMC Licensing & Product Registration Portal for applications of medical devices.

  • This is in line with DRAP’s vision to promote transparency, digitalization, and ease of doing business as part of its continued commitment to streamline regulatory procedures through digital transformation.
  • All importers and manufacturers of medical devices are directed to submit their applications on the new online MDMC Licensing & Product Registration Portal at this link commencing 21st July 2025 for the following application types:
    • New applications for the grant and renewal of establishment license to import and local manufacturer.
    • New and renewal applications for registration/enlistment of local manufacturer and import.
    • Post registration/enlistment variation and post license variation applications.
  • Manual manual submissions for the above functions will not be accepted from 21 July 2025.
  • Already online submitted applications for establishment licenses (local &
  • Import) shall continue to be processed using the existing e-DRAP portal.

Source: DRAP

Brazil
1 July 2025
Anvisa presents UDI system and regulatory updates on medical devices

The application and incorporation of the UDI to the set of brazilian regulatory standards were consolidated by the resolution of the Collegiate Board (RDC) 591/2021, whose main requirements for the sector come into force in July 2025.

  • The resolution also defined as essential the development, by Anvisa, of the national database of the UDI, the Unique Device Identification System. The preliminary version of the Siud User Manual can be accessed here.
  • In order to act in a coordinated manner, several areas are being involved in the system.
  • The goal is to reduce the impact for companies or other sectors and ensure that, with the participation of different actors, everyone can achieve the same result: improve patient safety and optimize supply chain management.
  • The adoption of the UDI system represents a step of great importance for the strengthening of traceability, transparency and safety of medical devices in the country.
  • More than a technological innovation, it is a regulatory advance aligned with international standards, which expands the monitoring capacity and contributes to the protection of public health in Brazil.

Source: Anvisa

European Commission
8 September 2025
Medical Devices and In-vitro diagnostics – targeted revision of EU rules

While the overall objectives of the MDR and IVDR are shared by all relevant actors, various stakeholder groups and institutional actors consider that a lack of sufficiently predictable timelines for the certification process and diverging practices across the EU are undermining the efficiency of the process to obtain the CE marking.

  • Moreover, several requirements under the Regulations are seen as disproportionate to the actual risks presented by the devices, which results in unnecessarily high costs and burdens
  • Overly onerous requirements may prompt manufacturers, especially SMEs, to discontinue the supply of devices or delay their launch, with potential negative impacts on the level of patient care and public health.
  • They may also negatively impact the competitiveness of the EU medical device market compared to other jurisdictions around the world.

This initiative seeks to simplify EU rules for medical devices and in vitro diagnostics. It aims to ensure availability of safe and innovative devices to safeguard a high level of patient safety, public health and healthcare.

Drawing on an evaluation of the current rules, the initiative seeks to:

  • make the EU medical device sector more competitive in the internal market and globally, to support innovation and reduce dependencies;
  • make safety requirements more cost-efficient and proportionate.

You can access the call for evidence document here.

You can provide your feedback here.

Consultation start date: 8 September 2025

Consultation end date: 6 October 2025

UK
4 September 2025
Open call for evidence Designated standards prioritisation

The MHRA is working to deliver a future regulatory framework for medical devices that

  • prioritises patient and public safety,
  • gives patients access to the medical devices they need, and
  • ensures the UK remains an attractive market for medical technology innovators. 

In line with this objective, it is committed to enhancing patient safety and harmonisation by more closely aligning with international standards and best practices.

  • The MHRA is seeking your input through this survey on the prioritisation for designation of important medical device standards that support compliance with the Medical Device Regulations 2002 (MDR 2002) (No.618 as amended).
  • Your feedback is crucial in helping shape the MHRAs approach to designating standards, ensuring that they are practical, effective, and beneficial for all stakeholders involved.
  • The findings from the survey will inform the MHRAs ongoing prioritisation process for device standards designated.
  • You may download the survey questions for reference, before responding to the survey.

Consultation start date: 4 September 2025

Consultation end date: 30 September 2025

Source: MHRA

21 July 2025
Medicines and Medical Devices Act 2021 – Stakeholder survey

The MHRA, in collaboration with the DHSC is conducting a review of the UK’s medicines and medical device regulatory framework, and they are seeking input from stakeholders across the sector, including patients and the public.

The focus of the review is the legislation that governs the development, authorisation, supply and oversight of medicines and medical devices in the UK. These include:

  1. Human Medicines Regulations 2012 (HMRs): which set out the regime for the manufacture, authorisation, supply, and pharmacovigilance of medicines.
  2. Medical Devices Regulations 2002 (MDRs): which provide the regulatory framework for medical devices, including requirements for safety, performance, and conformity assessment.
  3. The Medicines for Human Use (Clinical Trials) Regulations 2004: which govern the conduct of clinical trials of medicinal products.
  4. Medicines and Medical Devices (Fees) Regulations: which outline the fees payable to the MHRA in relation to regulatory services.
  • The purpose of this review is to evaluate whether the legislation is operating as intended now, if it continues to effectively protect public health, and avoids imposing unnecessary or excessive regulatory burdens.
  • The review is also looking at the structure of the legislation and whether restructure or consolidation would make the regulations clearer or easier to implement.
  • Please provide your views and experiences on the regulations which are relevant to you or your organisation, with specific examples where possible.
  • The findings from the completed survey will inform the Review and a report to be published by the Secretary of State for Health and Social Care.
  • All feedback will be anonymised in the final report.

You can download the survey questions here, for reference, before responding online to this survey.

Consultation start date: 21 July 2025

Consultation end date: 19 September 2025

Source: MHRA

21 July 2025
Medicines and Medical Devices Act 2021 – Stakeholder survey

The MHRA, in collaboration with the DHSC is conducting a review of the UK’s medicines and medical device regulatory framework, and they are seeking input from stakeholders across the sector, including patients and the public.

The focus of the review is the legislation that governs the development, authorisation, supply and oversight of medicines and medical devices in the UK. These include:

  1. Human Medicines Regulations 2012 (HMRs): which set out the regime for the manufacture, authorisation, supply, and pharmacovigilance of medicines.
  2. Medical Devices Regulations 2002 (MDRs): which provide the regulatory framework for medical devices, including requirements for safety, performance, and conformity assessment.
  3. The Medicines for Human Use (Clinical Trials) Regulations 2004: which govern the conduct of clinical trials of medicinal products.
  4. Medicines and Medical Devices (Fees) Regulations: which outline the fees payable to the MHRA in relation to regulatory services.
  • The purpose of this review is to evaluate whether the legislation is operating as intended now, if it continues to effectively protect public health, and avoids imposing unnecessary or excessive regulatory burdens.
  • The review is also looking at the structure of the legislation and whether restructure or consolidation would make the regulations clearer or easier to implement.
  • Please provide your views and experiences on the regulations which are relevant to you or your organisation, with specific examples where possible.
  • The findings from the completed survey will inform the Review and a report to be published by the Secretary of State for Health and Social Care.
  • All feedback will be anonymised in the final report.

You can download the survey questions here, for reference, before responding online to this survey.

Consultation start date: 21 July 2025

Consultation end date: 19 September 2025

Source: MHRA

India
12 August 2025
ICMR and CDSCO draft standard evaluation protocols for use by IVD manufacturers testing labs in India.

Licensure of In-Vitro Diagnostics (IVDs) under Medical Devices Rules 2017 requires a
detailed evaluation protocol for the performance evaluation of IVDs to evaluate their
quality and performance.

To facilitate this process, the Indian Council of Medical Research (ICMR) and CDSCO have drafted standard evaluation protocols for use by IVD manufacturers testing labs in India. Currently, the IVD evaluation protocols in this document have been developed by ICMR and CDSCO.

  • These protocols are now being placed in the public domain for comments from relevant stakeholders.
  • Once finalized, there will be minimal scope for change in these documents.
  • All interested stakeholders are requested to provide their comments before 25th August 2025, at ivdevaluation@gmail.com.

Consultation start date: 12 August 2025

Consultation end date: Before 25 August 2025

Source: CDSCO

Canada
25 September 2025
Consultation: Draft guidance on the plain language labelling regulations for prescription drugs

Health Canada is seeking feedback on proposed revisions to the Questions and Answers: Plain Language Labelling for Prescription Drugs Guidance Document.

Revisions to the current guidance document have been proposed to:

  • accommodate current style and format standards for web publication
  • add more examples of what types of plain language labelling changes should be submitted for review and what are considered Level III – Annual/Post-DIN Notifications
  • clarify the submission of second-language labelling materials
  • remove reference to safety and efficacy NCs
  • update guidance for abbreviated package inserts

You can read the the draft guidance for consultation here. A related document Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs is available here.

The focus of this consultation is:

  • the industry
  • health professionals

Your input and ideas are being sought to answer the following questions:

  • Do you believe that specific sections or statements would benefit from greater clarity (if so, please identify)?
  • Do you have additional suggestions for examples of Level III changes to propose for consideration?
  • Do you wish to share any other general suggestions or questions for consideration?

You can respond to the consultation with your ideas or comments by sending an email to policy_bureau_enquiries@hc-sc.gc.ca. Please be sure to include “Comments on revised PLL Q&A” in the subject line of the email.

Consultation start date: 25 September 2025

Consultation end date: 7 November 2025

Source: Health Canada

The Philippines
9 September 2025
Draft for Comments Implementing Guidelines of the World Health Organization (WHO) Collaborative Procedure (CRP) on the Registration of Pharmaceutical Products Approved by Stringent Regulatory Authorities (SRAs)

Across the globe, several low and middle-income countries face challenges in the
accessibility of medicines.

  • To address these and prevent their consequences to public health, the WHO developed a scheme that recognizes the scientific evaluation of stringent regulatory authorities (SRAs) that abide by WHO-aligned standards and allows such evidence to be used in streamlining the regulatory process for pharmaceutical products.
  • The FDA views its participation in the CRP as essential to the timely practice of regulatory reliance for the benefit of improving the public’s access to safe, efficacious, and quality-assured pharmaceutical products.
  • This Circular is hereby issued to guide and provide the procedures that shall be undertaken by the concerned stakeholders in the implementation of the WHO CRP of pharmaceutical products approved by SRAs.

Please submit your comments on the template, in MS word and PDF format via e-mail to cdrr.sds@fda.gov.ph.

Consultation start date: 9 September 2025
Consultation end date: 3 October 2025

Source: FDA Philippines

European commission
3 September 2025
Stakeholders’ Consultation on EudraLex Volume 4 – Good Manufacturing Practice Guidelines: Chapter 1

An update of Chapter 1 of the Good Manufacturing Practice (GMP) guidelines is necessary to establish efficient regulatory frameworks based on good science and risk management. 

  • This revision aligns GMP requirements with international best practices and adapts them to industry advancements, ensuring both the availability and the quality of medicines.
  • To maintain the global alignment of standards, this document has been revised by the EMA GMDP-Inspectors Working Group in cooperation with the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
  • The revised Chapter 1 reflects the updated ICH guideline on Quality Risk Management, ICH Q9(R1), strengthening knowledge management and risk management across the product lifecycle. 
  • Alignment with ICH Q9(R1) fosters a proactive, evidence-based culture that reduces variability in quality outcomes.
  • By embedding risk-based decision-making and emphasising scientific rationale and proportionality in risk assessment, it ensures consistent product quality and availability. 
  • The revision also stresses the importance of proactive identification of manufacturing risks to prevent shortages and mitigate supply chain vulnerabilities, thereby safeguarding patient safety and public health.
  • The guideline also clarifies requirements for product quality review, particularly regarding product grouping and situations where only a limited number of batches were manufactured during the review period.

If you wish to participate in the targeted consultation and you are a member of a stakeholders’ organisation, please contact your organisation to submit your comments.

If you wish to participate and you are not a member of one organisation, comments must be submitted via the EU Survey tool, using the specific table for each section of the guidelines.

Consultation start date: 3 September 2025

Consultation end date: 3 December 2025

Source: European Commission

14 August 2025
Public consultation on the Biotech Act.

On 4 August 2025, the European Commission commenced a public consultation on the Biotech Act.

  • The consultation is addressed to include citizens, innovators, entrepreneurs and industry.
  • The consultation strategy aims to ensure that all stakeholders concerned have an opportunity to express their views and share insights on the main challenges faced by the sector across the EU, the measures proposed, and their likely impact.
  • Stakeholders’ input will feed into the impact assessment for the future European Biotech Act.

Consultation start date: 4 August 2025

Consultation end date: 10 November 2025

Source: European Commission

Australia
12 August 2025
Joint consultation on updates to Good Manufacturing Practice (GMP) Guidelines

As digital technology and Artificial Intelligence (AI) transform medicine manufacturing, the GMP guidelines are being updated to ensure they remain current and effective.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has launched a public consultation on proposed revisions to its ‘Guide to GMP for Medicinal Products’. Key updates include:

  • Revised Chapter 4: Documentation
  • Revised Annex 11: Computerised Systems
  • New Annex 22: Artificial intelligence.

These updates have been developed by a joint PIC/S and European Medicines Agency Inspectors Working Group, with input from the Therapeutic Goods Administration (TGA). More information is available here.

  • If you’re an Australian manufacturer affected by these updates, your input is important. The PIC/S Guide to GMP is embedded in Australian law under the Therapeutic Goods Act 1989. 
  • It is the mandated standard for manufacturing therapeutic goods, including active pharmaceutical ingredients and sunscreens intended for human use.
  • It does not apply to blood products, certain cell therapies, or biologicals containing live animal material.

If you belong to a stakeholder organisation, please contact your organisation to submit your comments. You can also provide feedback directly using the survey tool on the European Commission website.

Source: TGA

Consultation start date: 12 August 2025

Consultation end date: 7 October 2025

European Medicines Agency & PIC/S
7 July 2025
Joint stakeholder Stakeholder Consultation on EudraLex Volume 4 – Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22

This joint stakeholder consultation on the PIC/S and EU GMP Guidelines concerns:

  • Revision of Chapter 4 – Documentation See revised draft.
    • The revised Chapter 4 incorporates changes which highlight the importance of documentation in GMP compliance and support the use of new technologies, hybrid solutions, and new services in the management of documentation.
    • Risk-management principles are now central and integrated within the data governance system to ensure the accuracy, integrity, availability, and legibility of documents across all formats—paper, digital, or hybrid.
    • All documentation, whether in text, image, video, or audio form, must remain complete and readable throughout its lifecycle.
    • The guideline also clarifies the requirements for the management of electronic records, signatures, and data integrity while ensuring consistency with the concurrent revision of Annex 11.
  • Revision of Annex 11 – Computerised Systems See revised draft.
    • The revised Annex 11 establishes enhanced requirements for the lifecycle management of computerised systems, mandating that Quality Risk Management principles be comprehensively applied during all steps.
    • The updated provisions reinforce obligations concerning the definition and ongoing maintenance of system requirements and the oversight of suppliers and external service providers.
    • Furthermore, the Annex strengthens controls related to the assurance of data integrity, audit trails, electronic signatures, and system security.
  • New Annex 22 – Artificial Intelligence See draft.
    • The new annex on Artificial Intelligence establishes requirements for the use of AI and machine learning in the manufacturing of active substances and medicinal products.
    • It sets up requirements for the selection, training, and validation of AI models. Emphasis is made on the definition of the intended use of the model, the establishment of performance metrics, the quality of model training data, and the management and processing of test data.
    • Annex 22 foresees a continuous oversight of AI systems, including change control, model performance monitoring and procedures for human review when necessary.

These 3 documents taken together aim at providing a comprehensive and robust framework that supports the implementation of IT technologies in pharma manufacturing while safeguarding product quality and patient safety.

If you wish to participate in the targeted consultation and you are a member of a stakeholders’ organisation, please contact your organisation to submit your comments.

If you wish to participate and you are not a member of one organisation, comments must be submitted via the EU Survey tool, using the specific table for each section of the Chapter/Annexes guidelines:

Target audience

  • Public health stakeholders involved in GMP activities
  • Organisations representing stakeholders involved in GMP activities are encouraged to take part in the consultation and to receive all the comments of this consultation from their members, to compile and send the comments via the EU Survey tool.

Further reading:

EU Consults on New GMP Rules for AI in Pharma Manufacturing, Rousannov et al, 10 July 2025, Arnold & Porter

Consultation start date: 7 July 2025

Consultation end date: 7 October 2025

Sources: European Commission, PIC/S

European Medicines Agency
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

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

FDA – US
10 September 2025
FDA Crackdown on Deceptive Drug Advertising

The U.S. HHS and the FDA today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements.

  • Today, the FDA is sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads. 
  • In addition to enforcing existing law, the FDA is initiating rulemaking to close the “adequate provision” loophole created in 1997, which drug companies have used to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust. 
  • By closing loopholes and stepping up enforcement, the FDA will protect patients, safeguard public health and hold the pharmaceutical industry accountable.

Source: FDA

8 August 2025
Report on the State of Pharmaceutical Quality

The annual report on the state of pharmaceutical quality 2024 has been published.

  • The report is intended to help characterize the quality of the U.S. drug supply chain.
  • It is updated each year to provide current and cumulative data about
    • pharmaceutical manufacturers
    • their products, and
    • postmarket quality defects
  • In addition, this report provides insights about
    • import alert additions
    • recalls, and
    • warning letters.  
  • The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality.
  • FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities.

Source: FDA

EU – Medicines for Europe
9 July 2025
Mandatory stockpiling in the EU: Rethinking today’s approach to protect tomorrow’s Generic Medicine supply

This report from Medicines for Europe proposes that although it is well-intentioned as a response to medicine shortages, current stockpiling policies are fragmenting the internal market, distorting supply chains, and undermining the long-term resilience and sustainability of generic medicine manufacturing and supply in Europe.

The report analyses the long-term structural risks posed by the growing trend of mandatory national stockpiling requirements in the EU and their disproportionate impact on the off-patent pharmaceutical sector.

Source: Medicines for Europe

DateCountry(ies)/RegionEvent
23 July 2025UKThe Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 was made into law on 23 January 2025 and will come into effect on 23 July 2025.

Further information is available in this post.
16 June 2025UKNew Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.

Further information in this post.
11 April 2025UKNew UK clinical trials regulations signed into law. More information in this post.
31 March 2025UKAs of 31 March 2025, the New Innovative Licensing and Access Pathway (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.
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 August 2025
Public Consultation for ICH Guideline Q3E “Guideline for Extractables and Leachables”

Swissmedic has commenced the Public Consultation for the Guideline Q3E of the (ICH Guidelines.

  • The ICH has developed guidelines on numerous aspects of impurities.
  • These include process and product-related substances (Q3A, Q3B), solvent residues (Q3C) and new guidelines for elementary (Q3D) and mutagene (M7) impurities.
  • However, there are no internationally harmonised guidelines for the evaluation and control of extractable and leachables (E&L) substances (Extractables and Leachables, E&L).
  • There is a lack of coordination, consensus and clarity between the existing guidelines, pharmacopeia and other standards for E&L.
  • This leads to uncertainties in industry and regulatory authorities, as expectations regarding E&L are unclear.
  • The proposed new quality guideline covers the following areas:
    • Chemical, biological and biotechnological products as well as combination products from pharmaceuticals and medical devices.
    • Cell and gene therapy products
    • All associated dosage forms, taking into account the extraction/lee conditions, the route of administration, the drug indication and patient exposure.

Comments can be sent to networking(at)swissmedic.ch using the re-registration form specified by the ICH.

Consultation start date: 22 August 2025

Consultation end date: 18 December 2025

Source: Swissmedic

23 July 2025
Adoption of ICH GCP Guideline E6(R3)

The ICH Guideline for Good Clinical Practice E6 establishes an international standard for the conduct, monitoring and documentation of clinical trials of medicinal products.

  • It is designed to safeguard participants’ safety and well-being and to help ensure the scientific integrity of the trial and the reliability of the results.
  • Although a revised version was issued in 2016, the need for a more comprehensive revision was apparent even at that time.
  • This was due to the growing complexity of trial designs, the increased use of new technologies, the greater volume of digital data and the increasing involvement of external service providers in the conduct of clinical trials.
  • These aspects have been taken into account in the ICH Guideline E6(R3), which is now available after a revision process lasting for several years.
  • It comprises a main document covering principles and objectives, Annex 1 (for interventional clinical trials) and Annex 2 (additional considerations for non-traditional interventional clinical trials).
DateEvent
6 Jan 2025The Principles and Annex 1 of the revised ICH GCP Guideline E6(R3) were adopted at the international level
23 Jul 2025The above came into effect in the EU region.
15 Aug 2025The above came into effect in Switzerland
No earlier than the beginning of 2026
Annex 2 of the revised ICH Guideline E6 is still undergoing a public consultation		Annex 2 will be adopted at a later date, coming into effect in the EU and in Switzerland

Source: Swissmedic

UK
12 August 2025
Consultation on the Revised ICH Guideline M4Q(R2)

The MHRA is consulting with UK stakeholders to gather feedback and comments on a revised international guideline to capture quality information for the registration and lifecycle management of pharmaceuticals for human use.

The new ICH M4Q(R2) (currently in draft status) guideline will revise and update the current ICH M4Q(R1) guidelines.

  • The introduction of the M4Q(R1) guidelines on the Common Technical Document (CTD) in 2002 harmonised the format of quality information for registration of pharmaceuticals for human use and offered great benefits to industry, regulators, patients, and consumers.
  • M4Q(R1) is now due for revision to further improve registration and lifecycle management efficiency, leverage digital technologies, and accelerate patient and consumer access to pharmaceuticals.
  • The focus of M4Q(R2) is the revision of CTD Quality sections in Modules 2 and 3 to capture quality information for the registration and lifecycle management of pharmaceuticals for human use.
  • The M4Q(R2) guideline would speed up patients and consumers’ access to pharmaceuticals while being of great benefit to both industry and regulatory agencies.

You can respond to the consultation via email at ichconsultations@mhra.gov.uk.

Consultation start date: 12 August 2025

Consultation end date: 26 October 2025

Source: MHRA

Ireland
24 July 2025
Revised Good Clinical Practice Guideline ICH E6 (R3)

The revised ICH Guideline for Good Clinical Practice (GCP), ICH E6(R3) which establishes an international standard for the conduct, monitoring and documentation of clinical trials of medicinal products, will become effective in the EU on 23 July 2025.

  • This update replaces the current version, ICH E6(R2), which was effective until 22 July 2025. 
  • The ICH E6(R3) Guideline consists of the following components:
    • Overarching principles and objectives
    • Annex 1, which provides guidance for interventional clinical trials
    • Annex 2, addressing non-traditional interventional clinical trial designs, is expected later in 2025

Key updates include:

  • Introduces innovative provisions applicable for many types of trials to ensure relevance as technology and methods advance
  • Encourages a risk-based and proportionate approach to trial conduct clinical trials
  • Enhanced transparency by reporting clinical trial registration and results
  • Additional guidance to support the informed consent process

The updated structure aims to improve clarity and usability for stakeholders including sponsors and investigators. 

Source: HPRA

Argentina
16 July 2025
Extension of consultation deadline for  ICH E6 R3 Guidelines on Good Clinical Practices

ANMAT confirmed that the  ANMAT-MED-BPC 001-01 Project “Standards on Good Clinical Practices, evaluation and supervision of clinical pharmacology studies for registration purposes and adoption by ANMAT of the ICH E6 R3 Guidelines on Good Clinical Practices” will extend the Public Opinion period until August 25 inclusive.

Source: ANMAT

Consultation end date: 25 August 2025

European Commission
8 August 2025
Study on the deployment of AI in healthcare

The report with the above title has been published. You can download it via this page.

Using a mixed methods approach, entailing a literature review and consultation activities, the study identifies a range of challenges to AI deployment in healthcare, spanning technological and data-related issues, legal and regulatory complexities, organisational and business challenges, and social and cultural barriers.

It also highlights successful strategies (accelerators) employed by hospitals globally to overcome these common obstacles, offering valuable inspiration in the broader European Union (EU) context.

Source: EU commission

10 July 2025
The General-Purpose AI Code of Practice

The General-Purpose AI (GPAI) Code of Practice published on 10 July 2025 (three weeks before the obligations relating to general purpose AI models under the EU AI act are due to come into effect) is a voluntary tool, prepared by independent experts in a multi-stakeholder process, designed to help industry comply with the AI Act’s legal obligations for providers of general-purpose AI models.

  • The Code of Practice helps industry comply with the AI Act legal obligations on safety, transparency and copyright of general-purpose AI models.
  •  In the following weeks, Member States and the Commission will assess its adequacy.
  • Additionally, the code will be complemented by Commission guidelines on key concepts related to general-purpose AI models, to be published still in July.
  • Read more about the timeline of the drafting process of the Code.
  • After the Code is endorsed by Member States and the Commission, AI model providers who voluntarily sign it can show they comply with the AI Act by adhering the Code.
  • This will reduce their administrative burden and give them more legal certainty than if they proved compliance through other methods.
  • More information on the code is available in this dedicated Q&A.
  • The three chapters of the Code are:
    • Transparency
    • Copyright
    • Safety and Security

Source: European Commission