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
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

13 June 2025
Regulation on Amendments to the Regulation on Clinical Investigation of Human Medicinal Products

Regulation number 32921 and titled “Regulation on Amendments to the Regulation on Clinical Investigation of Human Medicinal Products” was published in the Official Gazette dated 5 June 2025 and can be viewed here.

It is strongly announced to all interested parties.

22 May 2025
Reporting in clinical trials update

The Guideline for safety reporting in Clinical Trials  has been updated and  is available here.

A new application document type has been defined regarding the notification of serious adverse events resulting in death specified in this guideline to the Institution and the “Sample Cover Letter for Serious Adverse Event (CAO) Notification Resulting in Death” has been published. You can view it here.

In applications, up-to-date documents and appropriate application document types must be used as of 21 May 2025.

Source: TITCK

5 May 2025
Clinical research documents updated

The following documents have been updated and must now be used as of 2 May 2025:

Source: TITCK

Switzerland
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

30 June 2025
Nitrosamine impurities in medicinal products: updated requirements on risk assessments, data submission and parallel imports

the current information on Swissmedic supplements measures for risk assessment of possible nitrosamine contamination in active ingredients and finished medicinal products is available at the link below.

Source: Swissmedic

Introduction of a uniform labelling of drug safety communications (DHPC) and government-mandated information material

 From July 2025, Swissmedic is introducing specific labelling for DHPC including officially mandated information material.

  • In the future, all ”  Direct Healthcare Professional Communications ” (DHPC) approved by Swissmedic will be marked with the “Red Safety Information” symbol.
  • Communications not approved by the authorities may not bear this symbol.
  • Officially mandated information material is marked with the “Blue Safety Information” symbol, similar to the “Red Safety Information” symbol. This symbol may only be used to mark information material mandated by Swissmedic.
  • By creating a recognition value, the recipients of the DHPC and the information material should be able to identify this important safety information more reliably in the future and thus minimize information deficits.
  • Detailed information is provided in three documents via links on this page.

Source: Swissmedic

1 May 2025 (updated 18 June 2025)
Risk assessment regarding nitrosamines in active substances and/or finished medicinal products

Swissmedic enshrines the requirement to submit risk assessments regarding nitrosamines in active substances and/or finished medicinal products in the relevant specification documents.

  • The guidance document Formal Requirements is supplemented by Chapter 2.5.16 Risk assessment regarding nitrosamines in active substances and/or finished medicinal products .
  • This document specifies for which new marketing authorisation applications, Swissmedic requires a risk assessment of nitrosamines in the active ingredient and/or finished medicinal product, and which exceptions apply.
  • For example, these risk assessments are always required if the active ingredient of the newly approved human medicinal product is chemically synthetic or contains synthetic components.
  • New marketing authorisation applications for co-marketing medicinal products, for example, are exempt from the requirement to submit nitrosamine risk assessments.
  • In the “New Marketing Authorization” tab of the list of documents to be submitted , the added item 1.12.5 also clarifies that Swissmedic expects the risk assessment in Module 1 and to which specific new marketing authorization applications this requirement applies.
  • These formal requirements also apply in the EU.
  • The above-mentioned standard documents entered into force in an adapted version from 1 May 2025.
  • Update of 18 June 2025
  • The documents for the nitrosamine risk assessment should preferably be submitted as Additional Information in Module 1.
  • CTD does not have a Chapter 1.12.5. Alternatively, placement in CTD Chapter 3.2.P.5.6 ( Justification of Specification ) is also acceptable.
  • In this case, the placement must be indicated in the accompanying letter.

Source: Swissmedic

1 June 2025
Revision of the guidelines on deadlines for applications indication extensions under Project Orbis

Swissmedic is shortening the processing times for applications for indication extensions under Orbis Type A and accelerated Orbis Type B.

  • This revision is part of the ongoing development of the Project Orbis procedure and is intended to further increase the attractiveness of international procedures.
  • The new deadlines will accelerate the processing of applications for indication extensions for Orbis Type A and accelerated Orbis Type B procedures, thus enabling faster access to innovative medicines for patients.
  • Swissmedic has revised its guidance on deadlines for marketing authorization applications accordingly.
  • The new deadlines for applications for indication extensions for Orbis Type A and accelerated Orbis Type B will apply from June 1, 2025.

Source: Swissmedic

Updated PSUR/PBRER form for human medicinal products

The PSUR/PBRER form for human medicinal products has been revised.

  • The aspects affected by the RMP update regarding safety concerns, additional pharmacovigilance activities, and/or additional risk minimization measures must now be specified.
  • The RMP summary no longer needs to be submitted simultaneously.
  • Please also refer to the RMP ICH E2E Information Submission HAM guidance document.
  • The updated form PSUR/PBRER for human medicinal products will be valid from 1 June 2025.

Source: Swissmedic

28 May 2025
Revision of the guidance on GMP compliance by foreign manufacturers

For an application for authorization (new application) or a minor change of type IA/IAIN to be reported retrospectively, a minor change to type IB that must be reported in advance, or a major change to type II of an authorized human medicinal product, or for a new registration or a change with or without evaluation of an authorized veterinary medicinal product, certain documents must be submitted as evidence of GMP compliance testing of foreign manufacturers by the responsible person (RP).

  • According to the MPLO, it must be demonstrated that foreign manufacturers work in accordance with the GMP requirements applicable in Switzerland, so supporting documents should generally be issued by authorities whose GMP control system is considered equivalent.
  • If no such certificate is available, an audit report may also be submitted as proof of GMP compliance under certain conditions.
  • Swissmedic has provided clarification on the topics that must be taken into account during the audit, depending on the manufacturing activities applied for. General conditions for the submission of audit reports have also been added.
  • The guidance now also contains clarifications on the submission of inspection reports from authorities whose GMP control system is considered equivalent by Switzerland.
  • Inspection reports from recognized authorities are accepted if they are not older than three years, the inspection was carried out on site, and it relates to the medicinal product (active substance) or ready-to-use medicinal product in question.
  • The amended guidance document is applicable from 1 May 2025.

Source: Swissmedic

19 May 2025
Swissmedic and Swedish MPA sign a Memorandum of Understanding (MoU)

Swissmedic and the Swedish MPA signed a memorandum of understanding (MoU).

  • The agreement creates a formal framework for closer cooperation on regulatory issues associated with medicinal products and medical devices.
  • The signing of the memorandum underscores both authorities’ shared commitment to efficient, science-based therapeutic products regulation and to the promotion of public health by international cooperation.
  • Through the MoU, the Swedish MPA and Swissmedic are expanding information sharing and laying the foundations for greater cooperation on multilateral initiatives.
  • Using the agreement as a basis, it will be possible to promote reciprocal understanding of regulatory framework conditions, requirements and processes through the structured exchange of information and documents.
  • Additionally, cooperation between the two authorities in multilateral bodies will be strengthened.

Source: Swissmedic

Parallel import: Updates to the guide and the form

The guidance on importing a human medicinal product according to Article 14 paragraphs 2 and 3 of the TPA (parallel import) is clarified and adapted in some points.

  • An application for approval of a parallel-imported human medicinal product can only be accepted if the original medicinal product is authorized in Switzerland at the time of submission.
  • The post-market requirements regarding quality, safety, and efficacy are specified.
  • For example, if safety signals or quality defects are present in the original medicinal product (e.g., elevated nitrosamine levels), the importer may be required to implement any risk-minimizing measures.
  • The number of samples to be submitted is reduced to 1 sample pack per dosage strength.
  • The requirements regarding the GTIN code and LOT number are described in more detail.
  • The Swiss marketing authorization number and the package code must always be included, either within the GTIN code or as a separate text.
  • Further clarifications concern the marketing authorization status, such as the impact of a revocation/suspension of the original medicinal product on the parallel-imported medicinal product, as well as the consequences of a sales interruption for the original medicinal product.
  • The adapted guideline Import of a human medicinal product according to Art. 14 Para. 2 and 3 TPA (parallel import) and the adapted form Import of a human medicinal product according to Art. 14 Para. 2 and 3 TPA (parallel import) are valid from1 May 2025

Source: Swissmedic

1 April 2025
Adaptation of the guidelines for company meetings for approval procedures

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

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

Source: Swissmedic

UK
25 June 2025
Update – Medicines – variation forms for a manufacturer’s licence

An Updated attachment with the title Breakdown of fees for variations to manufacturer’s licences – F2 has been published.

Source: MHRA

17 June 2025
Medicines Guidance updated: get scientific advice from MHRA

The ‘Ask for scientific advice’  section has been updated to inform the user that the MHRA will not be able to process receipt of your request until we receive a complete list of Questions to be asked.

Source: MHRA

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

The document Updated guidance document paying online before submitting an annual safety report included in this guidance has been updated.

Source: MHRA

4 June 2025
Regulatory considerations for therapeutic use of bacteriophages in the UK

The MHRA has published the UK’s first official guidance to support the safe development and use of phage therapies – treatments that use viruses to target and destroy harmful bacteria.

  • The MHRA has compiled a document containing all the relevant regulatory guidance pertinent to the development of phage therapeutic products.
  • The guidance aims to help researchers and companies develop phage-based medicines that meet UK safety, quality and efficacy standards, so they can be made available to patients who need them most.
  • The MHRA document includes guidance for licensed and unlicensed medicines, from preclinical development to pharmacovigilance activities post-licensure.

Bacteriophages (also known as phages) are viruses that can infect and destroy bacteria.

  • There is a history of use for bacteriophages in the eradication of bacterial infections, including those resistant to antibiotics. Bacteriophages may also be of use in the treatment of infections in individuals unable to tolerate traditional antibiotics.
  • Current understanding is that although bacteriophages cannot infect and replicate in human cells, they play a part of the human microbiome.
  • Bacteriophages can have lytic (phage replicates, then breaks through the cell wall and destroys (lyses) the host cell) or lysogenic (phage DNA is incorporated into the host genome) lifecycles.
  • Phage therapy involves the use of bacteriophages to treat bacterial infections, which can be in conjunction with other antibiotics.
  • Routes of administration include, but are not limited to, oral, rectal, vaginal, intravesical, topical, intravenous, or inhalation.
  • Phage therapy may involve the use of a defined cocktail that shows effective killing of the patient clinical isolate, or, in some instances, a more personalised approach might be necessary.
  • Bacteriophages made with the intention of treating a medical condition in humans fall within the definition of a medicinal product.
  • Some bacteriophage medicinal products could also fall within the definition of gene therapy medicinal products (GTMPs), where genetic modification relates to therapeutic, prophylactic or diagnostic effect.
  • At the date of publication of the guidance, no marketing authorisations (MA; product licences) for bacteriophage medicinal products have been granted in the UK

Source: MHRA

Guidance updated: Regulatory Connect

Regulatory Connect is a service that provides the capability to track applications and view live authorisation details.

The guidance has been updated to add a link to the webinar of 22 May 2025. You can view the webinar here.

Below are salient points from the webinar:

  • The program uses the MHRA portal on gov.uk, Loren’s DocuBridge for eCTDs, and Microsoft Dynamics 365 [05:34].
  • It will feature increased automation, self-service capabilities for quicker approvals [08:14], transparent and traceable submissions [09:29], and strict data quality standards to minimize delays [10:05].
  • Regulatory Connect is being rolled out in phases.
  • The first release in March 2024 allowed industry to track submission statuses [10:44].
  • The next major release in Spring 2026 will transform product licensing regulatory services, enabling industry to manage licenses via the portal and launching Microsoft Dynamics 365 internally for the MHRA [10:52].
  • Future releases will cover notification systems, inspections, process licensing, and medical device registration [11:13 ].
  • Recent advancements include a new eCTD dossier management tool (March 2024) [12:16 ], a UK substance reference system (currently in public beta) [12:30 ], and extensive user-centered design activities [12:52].

Source: MHRA

3 June 2025
Guidance updated – Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel Imports

Sections 1, 2 and 4 of this guidance have been updated to reflect that the Windsor Framework was implemented on 1 January 2025.

Source: MHRA

13 May 2025
Guidance updated – International Recognition Procedure (IRP)

The validation checklist for the procedure has been updated. You can the updated checklist here.

You can read more about the IRP in this blog post.

Source: MHRA

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

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

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

Source: MHRA on LinkedIn

16 April 2025
Guidance – Risk minimisation measures for medicines

The MHRA has published guidance on risk minimisation measures.

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

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

The guidance is provided under the following headings:

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

Source: MHRA

Spain
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

13 June 2025
AEMPS update on the schedule for processing applications for marketing authorization of medicinal products for human use through the national procedure.

AEMPS has updated its timeline for marketing authorization applications for medicinal products for human use submitted through the national procedure , with the aim of improving processing efficiency.

  • This timeline will come into effect on 1 November 2025 and will allow applicants to understand the application deadlines from the submission of a valid application to the completion of the evaluation process, streamlining management and improving predictability regarding the evaluation status of the application.
  • During the evaluation of applications, up to three rounds of deficiency lists or requests for clarification may be submitted by the evaluating divisions along with a maximum period of 210 calendar days, which will commence from the day after a valid application is submitted.
  • Responses to these requests must be submitted exclusively through the eCTD system, in a sequence.
  • Only in the first round of clarifications, between calendar days 120 and 121, may an extension be requested. This extension must also be submitted sequentially, indicating “Extension at the request of the applicant” in the description. In this case, an automatic clock stop of up to 180 days will be applied.
  • Once the evaluation is completed, which will not exceed the maximum deadline, the AEMPS will request a single opinion from the Committee for Medicinal Products for Human Use (CMH) and will issue the corresponding final resolution.

See link below for further details.

Source: AEMPS

European Commission
13 June 2025
COMBINE programme launches a pilot coordinated assessment for clinical trials and performance studies

COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research.

As part of the COMBINE programme, the European Commission and EU Member States have launched a pilot project to test a new, more efficient way of approving combined studies. These studies involve both clinical trials of medicines and performance studies of medical devices.

This pilot:

  • is designed to allow sponsors of combined studies to submit a single application, ensuring more harmonised interactions with the Member States involved. This approach is expected to reduce the administrative burden for sponsors and promote transparency and consistency in the assessment process.
  • will accept a limited number of studies where the same sponsor is testing a medicine and a companion diagnostic at the same time. The aim is to see how well this new process works and to learn from the experience.

For more information and to apply for the pilot COMBINE coordinated assessment procedure, please visit the European Commission’s website.

Source: European Commission

3 June 2025
Planned maintenance of PSUR systems – Important notification

Due to planned maintenance, the PSUR Repository (Industry access) will not be functional during 20 – 22 June 2025.

  • During this downtime, the PSUR packages that are submitted through the EMA gateway will not be processed.
  • During the week 23 – 27 June 2025, the PSUR Repository and the PSUR submissions will be closely monitored, and even though all the potential scenarios were carefully considered, unforeseen disruptions could occur during this week.
  • To avoid any delays in sending the PSUR packages, it is highly recommended to submit the packages a few days before the 20th of June 2025.
  • For further details, please follow the EMA Service Desk and eSubmissions.

Source: eSubmission

USA
23 June 2025
CDER Nitrosamine Impurity Acceptable Intake Limits

On this page, the following updates have been made:

Added updated NDSRI timeline information below Table 4; revised footnote to Table 3

Source: FDA

12 June 2025
Submit an eCTD v4.0 or Standardized Data Sample to the FDA

The FDA would like to assist sponsors and applicants who have not previously submitted in eCTD v4.0.

  • It offers a process to validate sample new eCTD v4.0 submissions and standardized study datasets.
  • You must have an NDA, IND, BLA, ANDA, or MF number and plan to submit an actual submission to the FDA within 12 months of your sample request.
  • Sample submissions are not considered official submissions and are not reviewed by FDA reviewers at any time. 
  • When testing is complete, FDA will provide you with feedback, highlighting the errors found during the processing of the sample submission.

Further information at the link below.

Source: FDA

29 May 2025
CDER Nitrosamine Impurity Acceptable Intake Limits

On this page, Table 3: Recommended Interim AI Limits* for Certain Nitrosamine Impurities** for Approved or Currently Marketed Products has been updated. The Revision Table at the end of the page details the update.

Source: FDA

6 May 2025
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

The U.S. FDA announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients.

  • This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.  
  • In addition, the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight.
  • These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process.

Source: FDA

Further reading:

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities, Hogan Lovells 8 May 2025.

Canada
20 June 2025
New filing requirements for second language product monographs and package insert mock-ups: Notice

With immediate effect, Health Canada has updated its requirements for second language mock-ups and package insert mock-ups. The requirements are summarised in tables at the link below.

This change applies to the following product types:

  • biologic drugs (Schedule D)
  • radiopharmaceuticals (Schedule C)
  • pharmaceutical drugs (prescription and non-prescription)

Note that Package labels are not in scope of this change.

Source: Health Canada

Brazil
2 June 2025
Online Optimized Analysis Project to evaluate post-registration petitions for biological products

In May, Anvisa began a new phase of the Online Optimized Analysis Project, aimed at evaluating post-registration petitions for biological products by the Biological Products Evaluation Management (GPBIO). 

  • The initiative aims to speed up the analysis of these processes and reduce the regulatory queue for post-registration changes, currently estimated at around 24 months.
  • Even though it is still in its early stages, the strategy is already showing concrete results.
  • To date, 56 petitions have been completed, 27% higher than the monthly average of publications obtained since the beginning of the year.
  • The most recent publications are included in  Resolution-RE 2,021, of May 29, 2025 , published on 2 June 2025.
  • The goal is to maintain the fast pace over the coming months

Source: Anvisa

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

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

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

Source: Anvisa

Argentina
30 May 2025
ANMAT simplifies and accelerates the process for approving medicines

(ANMAT) has made a a number of modifications to simplify and accelerate the approval of medications as follows:

  • Prior to Provision No. 3752/25 published today in the Official Gazette, the authorization process for the “First Batch” of the medicine to be manufactured  had two evaluation stages of 45 business days each , plus the manufacturing and analysis times, provided that the laboratory did not have to provide additional information, which could cause said authorization to take more than four months to be granted. Now, with this reform, the deadline is shortened to 25 business days per stage and the documentation to be submitted in each case has been simplified and organized .
  • Another change is  the “simplified process,” which is reduced to a single step and is intended for over-the-counter products and others for which it may be considered feasible to perform an evaluation focussed only on manufacturing and quality results due to the long history of their pharmaceutical ingredients.
  • It should be noted that the changes introduced are part of the 
    plan to simplify procedures and update regulations that the National Institute of Medicines (INAME/ANMAT) has been promoting without compromising the standards of quality, safety, and efficacy required for medicinal products.

Source: ANMAT

Mexico
29 May 2025
COFEPRIS promotes more agile and efficient regulation within the framework of Plan Mexico.

COFEPRIS head Armida Zúñiga Estrada reported that, in compliance with Plan México, this health authority is implementing decisive actions to streamline processes, strengthen transparency, and modernize the regulatory framework aligned with international standards.

COFEPRIS is being transformed into an agile regulatory agency through:

  • the digitalization of procedures,
  • the simplification of processes, and
  • significant reductions in response times that directly impact the health sector and investment in the country

Among the advances presented by the head of COFEPRIS are the strategies developed that have yielded results in reducing processing times for clinical research protocols.

  • On March 24 of this year, as part of the processing time reduction scheme, the agreement establishing the criteria for the authorization of research protocols that have been previously authorized by highly recognized agencies, listed by the World Health Organization (WHO), was published in the Official Gazette of the Federation (DOF).
  • In this regard, Armida Zúñiga reported that the federal commission has now reduced the processing time for requests for research protocols by 65 percent, from 115 to 40 days; however, the goal is to provide a response within two weeks.
  • As part of the protocol-related actions, COFEPRIS is working in a strategic alliance with the Coordinating Commission of National Institutes of Health and High-Specialty Hospitals (CCINSHAE). This will increase the capacity to conduct high-quality clinical research through joint programs to train researchers; unified ethical and scientific criteria; and the strengthening of a network of clinical trial centers.
  • Another achievement presented during the morning conference was the deregulation and reclassification of medical devices based on risk level, which has simplified processes and eliminated unnecessary paperwork for 2,200 medical devices.
  • It is worth noting that this approach extends to other areas through more agile mechanisms such as notifications and alerts, aiming to shorten response times and foster a more dynamic environment for innovation and development in the health sector.
  • Also announced was the modernization of the regulatory framework for medicines and medical devices, which includes agreements recognizing good manufacturing practice certificates and registrations for these inputs, in addition to simplification agreements such as advertising permits, export certificates, and operating notices.
  • Among the strategic collaborations, the head of COFEPRIS spoke about the agreement signed in March of this year between this regulatory agency and the Mexican Institute of Industrial Property (IMPI) with the goal of establishing more agile mechanisms for linking patents and the granting of sanitary registrations. This has allowed consultations that previously took months to now only take five days.
  • As part of the current administration’s objectives, the commission is being positioned as a WHO Listed Authority (WLA), which will allow the health records we issue in Mexico to be recognized in other regions of the world.

Source: COFRPRIS

Australia
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

29 May 2025
Adoption of International Scientific Guidelines in Australia

Following a public consultation process between 21 November 2024 – 16 January 2024, the TGA has adopted 19 international scientific guidelines. You can view them at this link.

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

Malaysia
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

23 June 2025
Reminder: Submission of RiMUP for Evaluation by the Pharmacovigilance Section – Single Variation Only

As of April 2025, all RiMUPs for evaluation by the Pharmacovigilance Section, Centre of Compliance & Quality Control (PKKK) [previously requiring manual submission] should be submitted through the QUEST 3+ system.

Important:

RiMUP submissions for evaluation by the Pharmacovigilance Section should be submitted as a single variation only (bundling with other variation types is NOT acceptable, as the evaluation will be conducted by different officers).

Please ensure all other variations are submitted and approved, BEFORE submitting the RiMUP for evaluation by the Pharmacovigilance Section (i.e., no bundling).

3 June 2025
Screening Package for New Drug Products and Biologics

To enhance the submission process, NPRA has developed a dedicated Screening Package for New Drug Products and Biologics to provide clearer guidance and promote Good Submission Practice.

  • This package is designed to assist applicants in ensuring that their dossiers are complete and meet the necessary regulatory requirements prior to submission.
  • The package includes the following items:
    • A cover letter to describe the application
    • Screening Checklist
    • Annex 2b (Mandatory for products submitted via the Facilitated Registration Pathway)
    • Relevant forms which include:
      • a) Applicant Declaration on Post-Marketing Commitments
      • b) ACTD Part III: Non Clinical Documentation – Good Laboratory Practice (GLP) Compliance Form
      • c) Bioequivalence Study Report Submission Checklist
  • Guidance for industry

Effective 16 June 2025, all applications must be accompanied by the screening package.

More detailed information and links to the documents listed above are available at the link below.

Source: NPRA

Pakistan
24 June 2025
Guidelines for conduct and reporting of good clinical practice inspections

Edition 3 (16 June 2025) of the above guidelines have been published.

The updates to the guidelines are the following:

  • Inclusion of Risk Calculation of Clinical Trials
  • Revision of “RISK BASED SELECTION OF TRIAL /
    RESEARCH FOR GCP INSPECTION”
  • Inclusion of GCP Inspectors competency matrix, training
    requirements and minimum eligibility criteria.

Source: DRAP

Singapore
20 May 2025
NEX2US Newsletter

HSA has published Issue 11 of May 2025 of the above newsletter. It is packed with information on all recent regulatory updates. You can view it here.

Source: HSA

UK
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

9 June 2025
Guidance updated – Regulation of medical devices in Northern Ireland

This guidance has been updated to reflect implementation of Article 10a Notification of interruption or discontinuation of the supply of a medical device.

Source: MHRA

16 May 2025
Guidance – Manufacturer’s Online Reporting Environment (MORE)

The MHRA has published new implementation guidance to help medical device manufacturers prepare for changes to reporting requirements for serious safety incidents and field safety corrective actions in Great Britain (GB).

  • The new implementation guide for the Manufacturers Online Reporting Environment (MORE) clarifies the changing data requirements and timelines for compliance, before the new post-market surveillance regulations for medical devices come into effect on 16 June 2025.
  • Manufacturers should be aware of the following important dates:
    • early June – MHRA will release an updated schema and guidance for Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs), for the upcoming GB reporting requirements
    • 16 June – the new GB MIR and FSCA schema will be available in our MORE system, for manufacturers to us
    • 6 October – the latest date that manufacturers must start using the new GB schema to report incidents to MORE [via API (application programming interface) or post eXtensible Markup Language (XML) routes]
  • Reports for Northern Ireland may continue to be reported to the MHRA using the existing MIR 7.2.1 after 16 June 2025.

Source: MHRA

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

Australia
30 June 2025
New regulations to strengthen medical device patient safety

Australians who rely on medical devices will benefit from new measures introduced by the Australian Government to enhance the identification and management of device-related safety concerns. 

The TGA will now receive clearer identification and more detailed information about devices, allowing it to respond more quickly as and when issues are found. 

Patient safety will be strengthened through the following key initiatives:

  • Hospitals will have to report medical device adverse events to the TGA
    • Mandatory reporting of medical device-related injuries or suspected injuries will begin on 21 March 2026 for all public, private and day hospitals
  • Unique Device Identification System
    • Manufacturers supplying medical devices in Australia must use barcodes to identify their products on all packaging and labelling, and submit this data to the TGA.
    • Mandatory compliance with the UDI system for implanted devices will start from July 2026. 
  • Improved and clearer national recall processes
    • A stronger and more transparent process for recalling therapeutic goods in Australia has commenced, making it easier for suppliers and users to initiate and report product safety actions, and assisting the TGA in responding quickly and appropriately. 

Source: TGA

European commission
10 June 2025
Health Technology Assessment Regulation (HTAR) Capacity Building Programme

The HTAR Capacity Building Programme has been created to:

  • build long-term capacity & expertise of EU HTA bodies, so they can execute the HTAR effectively
  • enhance effective Joint Scientific Consultation (JSC) & Joint Clinical Assessment (JCA)
  • develop sustainable HTA capacity in view of the expansion of health technologies covered by the regulation over the next 5 years
  • prepare the HTA Community to tackle future challenges in EU healthcare

The primary target audience for the programme is HTA assessors, co-assessors and staff in HTA bodies of EU Member States and EEA/EFTA countries. Under certain circumstances, other stakeholders such as economic operators or individuals from EU Member States, EEA/EFTA, and non-EU countries may also participate.

EU HTAR experts have designed a training curriculum, organised into five modules, and will share hands-on experiences in interactive virtual classrooms. Each module includes:

  • a 4-hour, self-paced study handbook
  • one 4-hour, live session in a virtual classroom
  • virtual-classroom participants will also have access to an exclusive online community on the EU Academy Platform, offering follow-up tutoring by EU HTAR experts and networking opportunities.
  • A total of 20 virtual classroom sessions, hosted in English on Webex, will run from June-July 2025 to April 2026..
  • Five eLearning modules will also be available on in English and six other EU languages starting from the end of May 2026.

Further details are available at the link below.

Source: European Commission

29 May 2025
EMDN Helpdesk – officially live

The EMDN Helpdesk service is ready to respond to your request on the European Medical Device Nomenclature.  

The service, which is part of the Supporting the maintenance of the European Medical Device Nomenclature (SMEMDN) project co-funded by the European Commission, aims to provide users with information on the nomenclature structure (category/groups/types) as well as any useful information to enable manufacturers to choose the appropriate EMDN code(s) for their medical devices and in vitro diagnostic medical devices.

Source: European Commission

15 May 2025
Update – Notified bodies survey on certifications and applications

You can view the slide deck associated with this update here.

Source: EU commission

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

You can view the above here.

Source: European Commission

European Union
26 May 2025
EUDAMED Workshop – 21 May 2025

Below are links to the presentations from the above webinar.

Source: European Commission

Brazil
23 May 2025
Anvisa publishes preliminary manual on the Unique Identification of Medical Devices – UDI database

Anvisa has published the preliminary version for the operation of the Unique Device Identification (UDI) database.

  • Originating from the English Unique Device Identification (UDI), unique identification is an international identification standard that follows the rules of the International Medical Device Regulators Forum (IMDRF).
  • The objective of applying this standard is to facilitate the identification of medical devices on the market, mainly aiming to increase patient safety.
  • The internalization of the UDI into Anvisa’s regulations was launched by Collegiate Board Resolution (RDC) 591, of December 21, 2021.
  • The rule determined that the Agency should develop a national database for storing and consulting UDI information for each medical device registered in Brazil, a task that was considered a strategic priority by the Agency, integrating the 2024-2027 Strategic Plan (Strategic Project 02).
  • The preliminary version of the manual provides guidance on all database features that are already completed, but does not provide guidance on features that are still under development.
  • It is important to remember that Anvisa’s UDI database has not yet been published, and that it will only be available after the entry into force of the normative instruction that will result from Public Consultation 1,313/2025.
  • The deadlines for mandatory submission of information on UDI will be those already established in RDC 591/2021: 3 and a half years for class IV devices; 4 years for class III; 5 years for class II; and 6 years for class I, counted from the entry into force of the new normative instruction.

Source: Anvisa

European Commission
7 July 2025
Stakeholder Consultation on EudraLex Volume 4 – Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22

This consultation 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:

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

Source: European Commission

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.
European Medicines Agency
30 June 2025
ICH E20 Guideline on adaptive designs for clinical trials Step 2b

This document provides guidance on confirmatory clinical trials with an adaptive design
intended to evaluate a treatment for a given medical condition within the context of its overall development program.

  • For the purpose of this guideline, an adaptive design is defined as a clinical trial design that allows for prospectively planned modifications to one or more aspects of the trial based on interim analysis of accumulating data from participants in the trial.
  • The term prospectively planned means that the potential trial adaptations are pre-specified in the clinical trial protocol prior to initiation of the trial.
  • The scope of this guideline does not include trials with unplanned modifications to the design, such as a protocol amendment proposed by an independent data monitoring committee (IDMC) based on unexpected interim results.
  • It also does not include design changes based entirely on emerging information from a source external to the trial.
  • Routine monitoring of operational aspects such as the enrollment rate, data quality, or extent of participant withdrawal is also out of scope.
  • The focus of this guideline is on principles for the planning, conduct, analysis, and
  • 15 interpretation of trials with an adaptive design intended to confirm the efficacy and support the 16 benefit-risk assessment of a treatment

Comments should be provided using this template.

Consultation start date: 30 Jun 2025

Consultation end date: 30 Nov 2025

Draft for public consultation- QRD annotated template v11

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

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

Main proposed changes include: 

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

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

Use the form at this link to submit your comments.

Consultation start date: 14 April 2025

Consultation end date: 31 August 2025

Source: EMA

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


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

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

Comments should be provided using this EUSurvey form.

Further reading

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

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

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

Consultation start date: 1 April 2025

Consultation end date: 30 September 2025

Sources: EMA, Pinsent Masons

Anvisa – Brazil
5 May 2025
CMED public consultation on drug pricing criteria

The Executive Technical Committee of the Chamber for the Regulation of the Drug Market (CTE/CMED) will begin a public consultation on 12 May 2025 to review CMED Resolution 2/2004, which establishes the criteria for setting prices for new products and new presentations of drugs and the procedure for submitting the Price Information Document (DIP).

  • The objective is to update the standard, ensuring greater clarity and predictability in CMED procedures. 
  • The changes also aim to accommodate innovation in the pharmaceutical sector, resulting from the advances achieved over the last 20 years.
  • In this sense, specific rules are being incorporated for the pricing of radical and incremental innovation products, according to the clinical benefit provided and the degree of innovative activity undertaken in the country for the development of the product.   
  • The draft of the public consultation includes other advances for the pricing of medicines in Brazil, such as updating the basket of countries for external price referencing, clear definition of procedural rites, incorporation of rules currently provided for in communications, inclusion of definitions applicable to the resolution, rules for the application of provisional prices, as well as other aspects for improving the regulation of the national pharmaceutical market.  
  • The initiative seeks a solution that adheres to good regulatory practices and the provisions of Law 10.742/2003, in order to promote greater access by the population to innovative medicines and sectoral development, reconciling the interests of companies and citizens and generating investments for the country.  
  • Further information, including the Regulatory Impact Analysis Report (AIR), is available at this link.
    Public Consultation 1,330/2025 establishes a 60-day deadline for submitting comments and suggestions on the text of the proposal.
  • Interested parties may submit contributions using the electronic form available on the consultation page.

Consultation start date: 12 May 2025

Consultation end date: 11 July 2025

Source: Anvisa

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

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

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

Comments can be submitted using  this electronic form .

Consultation start date: 17 April 2025

Consultation end date: 13 October 2025

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

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

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

Pilot study start date: 1 August 2024

Pilot study end date: 31 July 2025

Source: NPRA

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

Spain – AEMPS
13 May 2025
AEMPS launches MeQA, a pioneering AI tool for answering questions about medicines for human use

AEMPS recently launched  MeQA , a pioneering tool based on artificial intelligence that allows users to perform natural language queries on medicines for human use, obtaining immediate responses based on official information extracted from product information leaflets.

  • MeQA allows you to perform natural language queries on medicines for human use and obtain immediate answers based on official information from product information leaflets.
  • The objective of this tool is to help citizens better understand what medications they take, why they take them and how they should do so.
  • This search engine represents a significant advance in transparency, improving access to reliable and quality health information.

Source: AEMPS

FDA – US
8 May 2025
FDA Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

In a historic first for the agency, FDA Commissioner Martin A. Makary announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.

  • The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.
  • To reflect the urgency of this effort, Dr. Makary has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June 2025.
  • Work will continue to expand use cases, improve functionality and adapt to the evolving needs of each center after June 30.
  • By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.
  • Looking ahead, the FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.
  • Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.

Source: FDA

Further reading

FDA advances AI-powered review of medical product applications, Robert Church et al, 19 May 2025, Hogan Lovells

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.
Canada
27 June 2025
Release of ICH guidelines for consultation
GuidelineConsultation
start date		Consultation
end date
Release of draft (step 2) ICH Guideline Q1: Stability Testing of Drug Substances and Drug Products27 Jun 202531 Aug 2025
Release of draft (Step 2) ICH Guideline M13B: Bioequivalence for Immediate-Release Solid Oral Dosage Forms27 Jun 202531 Aug 2025
Release of draft (Step 2) ICH Guideline M4Q(R2): Common Technical Document (CTD)-Quality27 Jun 202525 Sep 2025
Release of draft (Step 2) ICH Guideline E20: Adaptive Clinical Trials27 Jun 2025 25 Sep 2025
Release of draft (Step 2) ICH Guideline E21: Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials27 Jun 202525 Sep 2025
Release of draft (Step 2) ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP) – Technical Specification27 Jun 202515 Jul 2025

Source: Health Canada

Notice to stakeholders – Implementation of ICH M13A: Bioequivalence for immediate release solid oral dosage forms

The ICH’s guideline entitled, ICH M13A: Bioequivalence for Immediate Release Solid Oral Dosage Forms is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.

  • The ICH Assembly has endorsed the final draft and recommended its implementation by the membership of ICH.
  • The ICH M13A guideline should be read in conjunction with the relevant sections of other applicable Health Canada guidance documents.
  • By way of this notice, Health Canada is advising Canadians that the ICH M13A guideline will be implemented in Canada on December 27, 2025.
  • As a result, BE studies included in submissions filed after this date will be expected to comply with the ICH M13A guideline and this notice.

Source: Health Canada

European Medicines Agency
4 June 2025
Public consultation on the ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials Step 2b

This ICH guideline has been introduced to provide recommendations for the appropriate inclusion of pregnant and breastfeeding individuals in clinical trials. It will facilitate the generation of clinical data that allow for evidence-based decision-making on the safe and effective use of medicinal products during pregnancy and breastfeeding.

Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu

Consultation start date: 4 June 2025

Consultation end date: 15 September 2025

Source: EMA

Other countries are consulting on the same guideline as follows:

Switzerland

Consultation start date: 5 June 2025

Consultation end date: 15 September 2025

You can view the Swiss consultation here.

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

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

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

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

Consultation start date: 9 April 2025

Deadline for comments: 9 July 2025

Source: EMA

Brazil
22 May 2025
Call for contributions for the proposed ICH Q1 Guideline on Stability Testing of Drug Substances and Drug Products

The Call for Proposals 6/2025 , which will collect contributions for the proposed ICH Q1 Guide for Stability of Active Pharmaceutical Ingredients and Drug Products, is now open.

  • Anyone interested in the topic addressed by the guide can contribute, especially manufacturers and importers of active pharmaceutical ingredients and medicines, including biological products, professors and researchers in the field, other professionals, individuals and legal entities involved in the development and registration of medicines. 
  • Contributions can be made, preferably in English using the form 
  • http://pesquisa.anvisa.gov.br/index.php/648665?lang=pt-BR . 

Consultation start date: 22 May 2025

Consultation end date: 3 August 2025

Switzerland
12 May 2025
Public consultation for ICH Guideline Q1 “Stability Testing of Drug Substances and Drug Products” launched

Swissmedic has launched the public consultation on Guideline Q1 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines).

  • Most regulatory authorities successfully implement the ICH Q1 series (Q1A-Q1E), ICH Q5C, and the WHO stability guidance covering Climatic Zones III and IV (i.e., content of the withdrawn ICH Q1F) in the regulatory framework.
  • However, experience gained with implementation since the time these guidelines were finalised shows there are uncertainties related to the interpretation of the individual guidelines and how they fit together.
  • Additionally, it is recognised that innovation in analytical testing, including approaches as described in ICH Q2 and ICH Q14, along with the development of control strategies (ICH Q8 and Q11), Quality Risk Management principles (ICH Q9) and lifecycle approaches (as addressed in ICH Q10 and ICH Q12), create additional uncertainty for industry and regulatory agencies regarding how these pieces contribute to the assessment of product stability.
  • Through reorganisation into a combined core guideline ICH Q1 with topic-specific annexes/appendices, the updated Q1 Guideline will address specific topics beyond the core stability recommendations and principles (e.g. intermediates, devices, enhanced modelling).
  • The revision aims to promote harmonised interpretation by addressing potential gaps and areas of ambiguity, while also addressing technical issues around stability strategies, innovative tools for the application of risk management and stability considerations for advanced therapies.
  • Comments can be sent using the feedback form specified by ICH to networking@swissmedic.ch.
  • Links to the guideline and feedback form can be found at this link.

Source: Swissmedic

Consultation start date: 12 May 2025

Consultation end date: 30 July 2025

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

Consultation start date: 22 April 2025

Consultation end date: 9 July 2025

Source: Swissmedic

UK
9 May 2025
Consultation on the ICH M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms

The MHRA is consulting with UK stakeholders on the M13B guideline will focus on providing recommendations on obtaining waivers of BE studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths (‘in vivo’ refers to a medical test, experiment, or procedure that is done on (or in) a living organism, such as a laboratory animal or human). See the draft M13B guideline.

Consultation start date: 9 May 2025

Consultation end date: 31 July 2025

Source: MHRA

FDA (US)
2 June 2025
FDA Launches Agency-Wide AI Tool to Optimize Performance

Today, the FDA launched Elsa, a generative AI tool designed to help employees—from scientific reviewers to investigators—work more efficiently.

This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people.

Elsa is a large language model–powered AI tool designed to assist with reading, writing, and summarizing. It can:

  • summarize adverse events to support safety profile assessments
  • perform faster label comparisons
  • generate code to help develop databases for nonclinical applications.

These are just a few examples of how Elsa will be used across the enterprise to improve operational efficiency.

The agency is already using Elsa to:

  • accelerate clinical protocol reviews
  • shorten the time needed for scientific evaluations
  • identify high-priority inspection targets

The introduction of Elsa is the initial step in the FDA’s overall AI journey. As the tool matures, the agency has plans to integrate more AI in different processes, such as data processing and generative-AI functions to further support the FDA’s mission.

Source: FDA