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
21 October 2025
Guidelines on the Regulation of Pharmaceutical Product Certificate, Free Sales Certificate and Health & Free Sales Certificate Certificates
The guidelines with the above title entered into force on 15 October 2025 and applications are accepted electronically and signed electronically.
Certificate applications should be made from the Electronic Application and Process Management System (EBS-ESY)-Farmaseutic Product Certification procedures module, and the document fee document type application must be made from the EBS-ESY-Applications-General Document Application Add module.
Further details are available at the link below.
Source: TITCK
29 September 2025
Guidelines for the Issuance of Pharmaceutical Product Certificates, Free Sale Certificates and Health & Free Sale Certificates and Pharmaceutical Product Certification Unit Certificate Applications
The guideline with the above title has been published and will enter into force on 15 October 2025. You can view it here.
- Due to changes in the Pharmaceutical Product Certificate and Free Sales Certificate formats, physical documents for certificate applications in the old format must be submitted by 6:00 PM on October 3, 2025.
- As of the effective date of the guideline, certificates in the old format will no longer be approved.
- Therefore, for applications that have already been approved, document approval requests for the relevant document type must be submitted by 6:00 PM on October 14, 2025.
- Applications will be accepted electronically starting October 15, 2025.
- The Pharmaceutical Product Certification Procedures Electronic Application and Process Management System (EBS-ESY) User Guide for the application system is available here.
Source: TITCK
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.
UK
17 October 2025
Guidance updated: Borderline products – How to tell if your product is a medicine
The ‘Medicines Borderline Advice Form‘ accompanying this guidance has been updated.
Source: MHRA
15 October 2025
The new Innovative Licensing and Access Pathway (ILAP) welcomes first investigational products
From 16 applications in this first round, three investigational products with rare disease indications were awarded an Innovation Passport, the entry point into ILAP. While still in clinical development, they offer hope for the following conditions:
- Neonatal onset ornithine transcarbamylase (OTC) deficiency: a rare metabolic disorder that prevents the body from breaking down ammonia, often proving fatal in infancy without liver transplantation.
- Duchenne muscular dystrophy: a progressive muscle-wasting disease affecting 1 in 3,500 – 5,000 boys, currently with no cure.
- A rare neurodegenerative condition affecting children, with no current cure or treatment available.
The Innovation Passport gives developers coordinated support from the earliest stages of development, with priority access to services such as clinical trials support and NHS engagement, to help speed up access for patients where current treatment options are limited or non-existent.
You can read more about the ILAP pathway here.
Source: MHRA
9 September 2025
Form updates: Medicines: variation forms for a manufacturer’s licence
The following documents have been updated:
- Variation to an existing storage handling site – 14V
- Variation to add a contract laboratory site to an existing manufacturer’s licence/authorisation – 11V
- Variation to an existing process licence and/or authorisation: address – 3V
- Variation to nominate site personnel – MIA, MIA(IMP) and MS – 15V
- Variation to an existing process licence and/or authorisation: cover letter – 1V
- Variation to an existing contract laboratory named on an existing manufacturer’s licence/authorisation – 12V
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
Switzerland
1 October 2025
Update to the guidance of company meetings for admission procedures
In June 2024, Swissmedic introduced the preliminary decision Clarification Meeting as a pilot.
- Following analysis of the meetings held from this date, Swissmedic will conduct the Clarification Meeting after prior notice for medicinal products for human use from 1. October 2025.
- With the preliminary decision Clarification Meeting, the applicants receive an additional possibility to clarify the dialogue with Swissmedic for questions of understanding about the concerns that Swissmedic has communicated with the preliminary decision.
- A scientific dialogue with Swissmedic on the planned response strategy of the applicant is also possible.
- Further information on the application and implementation of the preliminary decision Clarification Meeting can be found in the management of company meetings for admission procedures.
- The updated management of company meetings for admission procedures will commence from 1 October 2025.
Source: Swissmedic
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
Belgium
20 October 2025
Communication from the Belgian Competition Authority on information exchanges between pharmaceutical companies in the context of the reimbursement application procedure for combination therapies
The communication with the above title was published by the Belgian competition authority on 11 September 2025.
- The competent authorities and the pharmaceutical sector consider that there are obstacles to the availability of combination therapies on the Belgian market, in particular due to the current procedure for the reimbursement of medicines by the National Institute for Health and Disability Insurance (NIHDI).
- In order to facilitate the bringing of combination therapies to market, the NIHDI is considering the adoption of a specific reimbursement application procedure, to be introduced individually and in parallel by the pharmaceutical companies involved in a combination therapy.
- As part of the implementation of this Procedure, the Belgian Competition Authority has been asked to clarify the conditions under which pharmaceutical companies may exchange information to facilitate the development and the bringing to market of novel combination therapies for the benefit of patients suffering from serious diseases.
Source: Belgian Competition Authority
This article by Nele De Backer et al of A&O Shearman on life sciences may help you to understand the BCI communication.
14 October 2025
FAMHP to accelerate the evaluation of clinical trials starting 2026, to allow faster access to innovative treatments
From 1 January 2026, the FAMHP will introduce accelerated timeframes for the evaluation of initial clinical trial applications for drugs for human use.
- This measure will make it possible to start clinical research more quickly, for the benefit of patients, while strengthening Belgium’s leading position as a clinical trial centre.
- The accelerated timeframes will impact clinical trials for all of the following products and phases:
- Mononational – Phase I, Phase I/II, Phase II
- Mononational – Phase II/III, Phase III, Phase III/IV, Phase IV
- Multinational (pilot phase) – Phase I, Phase I/II, Phase II
Further detailed information is available at the link below.
Source: FAHMP
Spain
16 October 2025
AEMPS consolidates project to eliminate paper package leaflet for hospital medicines
This initiative involves the replacement of the paper package leaflet with the information available in the AEMPS Online Medicine Information Center (CIMA), accessible through a Datamatrix code incorporated into the primary packaging.
- AEMPS launched this project in January 2022 given the limited use of the paper package leaflet in medicines of hospital scope, since health professionals usually access the information of the technical data sheet available in CIMA.
- Following this first test, the second phase of the pilot project began in June 2023, which incorporated new drug presentations.
- Once completed, the Spanish Society of Hospital Pharmacy (SEFH) carried out a last survey whose results reflect a positive assessment of the initiative and confirm that, in the vast majority of cases, neither health professionals nor patients request the package leaflet on paper.
- Here, AEMPS reports on the consolidation of the pilot project on access to electronic information for medicines in the hospital.
- In view of these results, AEMPS announces the consolidation of the pilot project, which will continue to be active without the forecast of new surveys.
- Following favorable results obtained in the second phase of the pilot, the project will continue, allowing the inclusion of new drug presentations
- Medicinal products that are included in the project must be exclusively for hospital administration.
- The companies concerned may submit their application for participation until 16 November 2025 to the Department of Human Drugs of AEMPS.
- Once the received applications have been reviewed, the Agency will publish an information note with the list of the drug submissions selected to join the project.
Source: AEMPS
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
Ireland
10 October 2025
Prepraring for New EU rules for substances of human origin (SoHo)
New EU rules for substances of human origin (SoHO) will replace existing regulations for blood, tissues, and cells.
- These changes will start from 7 August 2027, with some parts delayed until 2028.
- Organisations working with these substances must prepare for compliance with the new regulations. To support compliance, it is important to stay informed about developments as implementation progresses.
- The HPRA will publish updates in the relevant areas of the site:
Source: HPRA
Sweden
9 October 2025
Updates to the Ethical Rules of the Pharmaceutical Industry in Sweden1
In Sweden, the Ethical Rules for the Pharmaceutical Industry (LER) for a key framework governing how pharmaceutical companies communicate and collaborate with healthcare professional.1
- Managed by the Swedish Association of the Pharmaceutical Industry, LER complements existing legislation, regulatory provisions, and directives issued by relevant authorities.1
- On 29 September 2025, amendments to the Ethical Rules for the Pharmaceutical Industry (LER) entered into force.1
- Here, you can view the updated rules.
Further details are available at the link below.
Reference:
- Updates to the Ethical Rules of the Pharmaceutical Industry by Beatrice Rist et al, 1 October 2025, DLA Piper
Source: DLA Piper
Germany
8 October 2025
New validation criteria for eCTD submissions mandatory from December 2025
As of 1 December 2025, the new eCTD validation criteria v8.2 and the EU eCTD M1 specification v3.1.1 will be mandatory for all eCTD submissions.
- October and November 2025 will be used as a transitional period.
- BfArM advises on reading up about the upcoming technical changes in good time.
- Further information regarding the new validation criteria can be found on the eSubmission website:
Source: BfArM
European Medicines Agency
2 October 2025
EMA advice on end-of-year submission dates for type I variations in 2025
- Type IA and type IAIN variations and super-groupings
- MA holders are advised to submit individual type IA and type IAIN variations and super-groupings for 2025 no later than 21 November 2025.
- This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 23 December 2025 and 5 January 2026, within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.
- Annual updates should be submitted according to the timelines stated in the revised Variation Regulation and published guidance on application of revised variations framework.
- Type IB variations or groupings of type IBs and type IAs
- MA Holders holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 30 November 2025 for a start of procedure in 2025.
- For submissions received on or after 1 December 2025, the procedure may not start until January 2026.
Source: EMA
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
USA
23 October 2025
FDA publishes filing checklists used by CDER, to prevent submission delays
The U.S. FDA made public, filing checklists used internally by CDER staff to determine if a submitted application is complete and reviewable.
- By proactively posting CDER’s checklists, the agency aims to increase transparency into FDA filing procedures and reduce the prevalence of filing deficiencies, which consume resources and delay promising treatments.
- Moving forward, sponsors will be able to see a checklist for each review discipline which performs a filing review.
- The checklists were published in the latest update of CDER’s MAPP 6025.4 Good Review Practices: Refuse to File.
- It is important to note that while these checklists may be an invaluable tool for sponsors, they are not necessarily comprehensive.
- Filing checklists for Abbreviated New Drug Applications were published previously in MAPP 5200.14 Rev. 1.
Source: FDA
20 October 2025
eCTD Submission Standards
- eCTD Submission Standards for eCTD v3.2.2 and Regional M1 – Updates to Specification for eCTD Validation Criteria, Removed XLS version of Validation Criteria.
- eCTD Submission Standards for eCTD v4.0 and Regional M1 – Updates to Specification for eCTD Validation Criteria and FDA Regional eCTD v4.0 Module 1 Implementation Guide.
Source: FDA
20 October 2025
17 October 2025
FDA Awards First-Ever National Priority Vouchers to Nine Sponsors
The U.S. FDA announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program.
- Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing.
- Voucher recipients will receive a decision within 1-2 months following filing of a complete application for a drug or biologic.
- In addition, sponsors will receive enhanced communications with review staff throughout the development process prior to their final submission and during the review period.
- If necessary, FDA scientists reserve the right to extend the review time if an application is incomplete, there are manufacturing violations, or as they otherwise deem appropriate.
The agency anticipates announcing another group of CNPV recipients in the coming months.
Source: FDA
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
Argentina
9 October 2025
ANMAT approves standards on GCP for the evaluation and supervision of clinical pharmacology studies for registration purposes
ANMAT has approved the standards on good clinical practices for the evaluation and supervision of clinical pharmacology studies for registration purposes are approved.
The International Council on Harmonization’s (ICH) E6 Good Clinical Practice Guideline (Version R3) is adopted for clinical pharmacological trials for registration purposes.
You can view the full text here.
Source: ANMAT
Brazil
1 October 2025
Anvisa signs e-CTD (electronic Common Technical Document) contract
On 1 October, Anvisa signed the e-CTD (electronic Common Technical Document)
contract , which allows drug applications to be submitted in the format used by the world ‘s leading drug regulatory agencies.
This tool is seen as a priority for the pharmaceutical sector and is considered essential for streamlining technical analyses .
Source: Anvisa
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.
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
Australia
1 October 2025
Therapeutic Goods Legislation Amendment effective from 1 October 2025
The TGA is responsible for protecting the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance, and quality.
- This is achieved via the application of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and associated legislation.
- The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods and the testing it conducts assesses compliance with quality and performance standards for the therapeutic goods.
- This testing provides TGA with scientific data to inform and support regulatory decisions and actions, ensuring the safety of therapeutic goods for Australian consumers.
- Part 5 of the Regulations (Part 5) sets out procedures for testing of goods to be conducted under the Regulations.
- An internal review of Part 5 identified reform opportunities to ensure that the part is well designed for its purpose, can accommodate the latest and future innovations and testing methodology, is efficient to administer, and is transparent and flexible.
- Following a consultation in August 2024, on 1 October 2025, the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025 will amend the Regulations to repeal and replace Part 5.
- The purpose of these amendments, broadly, is to improve the clarity and functionality of Part 5.
- The new Part 5 authorises the Secretary to nominate APS employees as analysts who may select and test samples of goods under the part for the purpose of the administration of the Act or legislation made under the Act.
- The new part provides for testing to be conducted by an analyst, or by another appropriate person or body.
- At the completion of testing under Part 5, an analyst must issue a certificate which documents the testing conducted and the results of the testing.
- The certificate may also contain other information relating to the sample tested or the testing conducted.
- Transitional arrangements ensure continuity of testing of goods, as certain goods obtained by the department prior to commencement of the amendments may still need to be tested under Part 5 as in force prior to these amendments.
Source: TGA
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:
- ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
- Guideline on quality documentation for medicinal products when used with a medical device.
- 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
Sri Lanka
14 October 2025
Certificate of Analysis- New Format Update
The previous Certificate of Analysis has been replaced with a revised new report format, which includes four copies printed in four different colours. Click here for the new CoA format.
Source: NMRA
Japan
14 October 2025
Information on new drug review with electronic data updated
According to the PMDA, the information on this page has been updated. However, the nature of the update is unclear as no further information has been provided.
Source: PMDA
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
Singapore
30 September 2025
Launch of eCTD Portal for test submissions
HSA announced the launch of eCTD Portal for test submission, effective 30 September 2025.
- The test submission phase will be open for six months from 30 September 2025 to 27 March 2026.
- During this period, companies are encouraged to submit test submissions to familiarise themselves with the new system.
- Please note that all submissions made during this test phase will not be processed for regulatory review and will be removed from the system upon completion of the test period.
- Actual dossier submission in eCTD format will be accepted from 1 April 2026 onward.
- You may access the eCTD portal here to obtain your eCTD identification (eCTD ID) and transmit your eCTD packages.
- To support users in navigating the new system effectively, HSA has prepared comprehensive resources, including the training presentation, Q&A document and a portal user manual.
- For test submission, please use dummy application numbers only. No actual applications should be submitted through PRISM during this test phase.
Source: HSA
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
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
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:
- 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.
- 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.
- 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.
- 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 following eligibility criteria for drug registration applications to qualify for quality-based priority review:
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
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
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
Spain
21 October 2025
The Council of Ministers approves the new Royal Decree of medical devices for in vitro diagnosis
The Council of Ministers has approved the text of the new Royal Decree of medical devices for diagnosis in vitro.
- The text, at the same time, repeals the previous regulations (Royal Decree 1662/2000, of 29 September) with the exceptions contained in the transitional provisions and in the derogatory provision of the rule.
- This new regulation complements Regulation (EU) 2017/746, which established a new regulatory framework for diagnostic medical devices in vitro with the aim of ensuring a high level of safety and protection of the health of patients and users, based on transparency and sustainability.
- This royal decree specifies different aspects that the regulation leaves to the regulation of each Member State including:
- The determination of the competent authority for the purposes of the regulation and the establishment of the language system.
- The manufacture of products for use in the health center itself (commonly called in house).
- Genetic testing, genetic information and necessary advice prior to testing and after testing.
- European reference laboratories. The characteristics of the marketing register in Spain.
Source: AEMPS
UK
10 October 2025
Guidance updated- Register medical devices to place on the market
This guidance has been updated with the addition of the guidance Preparing for the implementation and management of the new device registration fee to help you prepare for the introduction of the new fee from A1 April 2026. You can view the guidance here.
Source: MHRA
8 October 2025
UK & US regulators forge new collaboration on medical technologies and AI
Patients will benefit as UK and US regulators forge new collaboration on medical technologies and AI’
- Strengthened collaboration between the UK MHRA and US FDA to drive innovation and accelerate patient access to latest technologies
- The MHRA National AI Commission launched with UK and US experts to shape safe, transparent use of AI in healthcare
- New international reliance routes to improve international investment and UK access to medical devices already approved by trusted regulators, including the US FDA .
Source: MHRA
6 October 2025
Guidance
Guidance updated: Clinical investigations for medical devices
The MHRA has updated the document, ‘Clinical investigations of medical devices – guidance for manufacturers‘ (Version 11.1 Oct 2025) to reflect the following changes: –
- Clarify that EU MDR can be met for GB only studies (page 4) –
- Updated point 5 on when application to MHRA is required and
- added links on where to find MHRA flow charts (page 6) –
- Some formatting changes also made.
Source: MHRA
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
Singapore
2 October 2025
HSA-SMF Partnership Pioneers Integrated Regulatory Support for MedTech Industry to Promote Access into Singapore and Other Markets
From 2 October 2025, the HSA and the Singapore Manufacturing Federation Medical Technology Industry Group (SMF MTIG) are pioneering a comprehensive support ecosystem for Singapore’s MedTech industry through their strategic partnership, combining the SME Centre@SMF’s services with HSA’s Health Products Regulation Group (HPRG) Innovation Office’s technical regulatory expertise.
- This dual-pronged approach transforms the regulatory journey from reactive compliance to proactive guidance, offering early consultations during product development or registration.
- It also promotes awareness to HSA’s agile frameworks and new initiatives such as the mutual reliance pilot between Medical Device Authority (MDA) of Malaysia and HSA.
- Signed on 22 August 2025, the Medical Device Regulatory Reliance Programme with Malaysia runs from 1 September 2025 to 28 February 2026, facilitating faster registration processes for Class B, C and D medical devices.
- HSA has established reliance programmes with Australia, Hong Kong, Philippines, Thailand, and Sri Lanka, which companies can tap on to reduce time-to-market.
- As of September 2025, more than 500 applications of medical devices have been processed through Thailand and Australia’s reliance on HSA’s approval.
- The strategic alignment between regulatory excellence (See Annex A of the source at the link below for details) and industry support infrastructure positions companies to capitalise on Singapore’s growing international regulatory influence while receiving the guidance needed to navigate these accelerated approval processes effectively.
Further information is available at the link below.
Source: HSA
Switzerland
1 October 2025
Swissdamed UDI Devices Module
The Discard function for the swissdamed UDI Devices module is now available.
- Registered UDI-DIs can be discarded if they contain incorrect data that cannot be corrected by an update due to Business Rules.
- The Discard function must not be applied in the event of changes to the product, but is used exclusively to correct incorrectly submitted data.
- With the Discard function, UDI-DIs are deleted from the system, are no longer visible in the public search, but can be registered again.
- Detailed information can be found at:
Source: Swissmedic
19 September 2025
Swissdamed technical documents
The following are available in the technical documentation on the Swissmedic website.
- The swissdamed business rules
- The data dictionary for the swissdamed module UDI Devices
- additional technical specifications for the upload of data to swissdamed (at the link below)
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
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
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
India
8 October 2025
Consultation to ensure a level playing field for new drug approval in India
This consultation concerns the requirement for conducting clinical trials and bioequivalence (BE) study for a new drug application. The question under deliberation is whether it should continue to be acceptable that once a new drug is approved for the first applicant based on clinical trial data and bioequivalence data, whether other applicants seeking approval for the same drug should be allowed to simultaneously submit the BE study report and obtain approval for the same new drug as a subsequent application i. e. are not required to conduct a clinical trial.
Consultation start date: 8 October 2025
Consultation end date: 7 November 2025
Source: CDSCO
Australia
7 October 2025
Public consultation launched on GMP Guidelines on Chapter 1 – Pharmaceutical Quality System
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has launched a public consultation on proposed revisions to its ‘Guide to GMP for Medicinal Products’, specifically Chapter 1 – Pharmaceutical Quality System. Key updates include:
- Revision of the chapter to incorporate changes introduced in ICH Q9(R1) on Quality Risk Management
- Additional guidance for the conduct of Product Quality Reviews.
These updates have been developed by a joint PIC/S and European Medicines Agency Inspectors Working Group. More information is available in the PIC/S news article – external site.
- 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 (e.g. Industry peak body), PIC/S have requested that feedback is submitted through your stakeholder organisation. You can also provide feedback directly using the survey tool EUSurvey.
Consultation start date: 7 October 2025
Consultation end date: 3 December 2025
Source: TGA
The Philippines
6 October 2025
Classification of Pharmaceutical Products Intended for Human Use – Draft for comments
Under the previous regulatory framework, pharmaceutical products in the
country were classified into:
- ethical or prescription drugs,
- dangerous drugs or List A drugs, and
- over-the-counter (OTC) drugs, including household remedies.
- Each classification corresponds to a defined level of risk and may require medical supervision, which regulates the extent of consumer access.
RA No. 10918, otherwise known as the “Philippine Pharmacy Act”, amended this classification by introduction of “pharmacist-only OTC medicines”.
- As part of the implementation of the provisions outlined in AO No. 2024-0013,entitled, “Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended for Human Use”, this Circular sets forth the detailed implementing guidelines for the classification and reclassification of pharmaceutical products intended for human use.
- This Circular aims to provide guidelines and regulations on the classification and reclassification of pharmaceutical products for human use.
- It also aims to provide the list of active ingredients and its classification and the specific labeling requirements for pharmacist-only non-prescription pharmaceutical products.
- This Circular covers all FDA-licensed pharmaceutical establishments handling pharmaceutical products for human use.
- All pharmaceutical products are classified according to the safety profile of the active ingredient, and the finished pharmaceutical product and how it may be accessed by patients/consumers in the market.
- Pharmaceutical products shall be classified as either
- prescription pharmaceutical products or
- non-prescription pharmaceutical products.
- Non-prescription pharmaceutical products shall be further classified as:
- pharmacist-only non-prescription pharmaceutical products or
- general sales non-prescription pharmaceutical products, which includes household remedies.
You can respond to the consultation using this form.
Consultation start date: 6 October 2025
Consultation end date: 31 October 2025
Source: FDA ,The Philippines
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
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
MHRA – UK
UK clinical trial approval times twice as fast with AI and reforms
The time it takes to approve clinical trials in the UK has been cut by more than half – from an average of 91 days to just 41 days – following major reforms backed by new digital platforms at the MHRA, new research confirms.
- Findings published this week (6 October) in the British Journal of Clinical Pharmacology (BJCP), show the reforms are delivering consistently strong results, with 99% of applications reviewed within statutory timelines, and most completed well ahead of target.
- The study is the first comprehensive review of the MHRA’s new way of reviewing trials based on their level of risk, introduced in 2023, showing how it speeds up review timelines while protecting patient safety.
- A fast-track route allows some lower-risk studies to be approved in just 14 days.
- Building on this, artificial intelligence (AI) is now being introduced to further support assessors – helping review complex data and improve consistency – while final decisions continue to rest with experienced assessors to ensure patient safety.
Source: MHRA
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
| Date | Country(ies)/Region | Event |
|---|---|---|
| 23 July 2025 | UK | The 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 2025 | UK | New 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 2025 | UK | New UK clinical trials regulations signed into law. More information in this post. |
| 31 March 2025 | UK | As 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 2025 | EU | European Health Data Space Regulation (EU) 2025/327 entered into force. You can read about it in this post by J. Grieb ety al. of McDermott Will & Emery. |
| 31 Jan 2025 | EU | From this date, the clinical trials regulation 536/2014 becomes applicable. All clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are now governed by the Clinical Trials Regulation (EU) No 536/2014 (CTR). This marks the end of a three-year transition period, during which more than 5,000 clinical trials were transitioned to the CTR through submission to the Clinical Trials Information System (CTIS), the single-entry point for sponsors and regulators for the submission and assessment of applications for clinical trials in the EU. Further information is available form the EMA here and in this blog post. |
| 30 Jan 2025 | UK | New Innovatiive Licensing and Access Pathway (ILAP) launched. |
| 1 Jan 2025 | UK | Windsor framework comes into operation. More information in this blog post and this blog post. |
| 1 Jan 2025 | EU | Amended Variations Regulation (EU) 2024/1701 implemented. more information in this blog post. |
Switzerland
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).
| Date | Event |
|---|---|
| 6 Jan 2025 | The Principles and Annex 1 of the revised ICH GCP Guideline E6(R3) were adopted at the international level |
| 23 Jul 2025 | The above came into effect in the EU region. |
| 15 Aug 2025 | The 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