GMP Developments - Update 2025/2026
Once again, 2025 saw a number of significant developments in the GMP environment. The following article summarises a few selected highlights. Changes relating to investigational medicinal products are addressed in a separate article.
Europe
Drafts of EU GMP Guideline Annex 11, Annex 22, and Chapter 4 released for Consultation
On 16 November 2022, the European Commission published a Concept Paper on the planned revision of EU GMP Annex 11 on computerised systems. On 07 July 2025, drafts of Annex 11 “Computerised Systems”, a new Annex 22 “Artificial Intelligence”, and a revision of Chapter 4 “Documentation” of the EU GMP Guidelines were issued.
All three drafts were open for consultation until 07 October 2025.
Revision of EU GMP Chapter 1 (consultation phase)
The European Commission launched a consultation on the revision of Chapter 1 of the EU GMP Guidelines. The consultation period ran until 03 December 2025.
The proposed changes concern three areas:
- Quality Risk Management (QRM)
- Knowledge Management (KM)
- Product Quality Review (PQR)
European Shortages Monitoring Platform (ESMP) operational
The European Shortages Monitoring Platform (ESMP) became fully operational on 29 January 2025, ahead of the scheduled date of 02 February 2025. Since then, all Marketing Authorisation Holders (MAHs) have been obliged to use this platform exclusively to report information on medicinal product shortages and availability.
In addition to the routine reporting obligations for centrally authorised products introduced in November 2024, the full functionality of the ESMP is now available for both MAHs and National Competent Authorities (NCAs). MAHs and NCAs can now use the platform for comprehensive reporting activities.
Critical Medicines Act published
To prevent future shortages and enhance supply security, the European Commission proposed the “Critical Medicines Act” on 11 March 2025. The proposal incorporates the results and recommendations of the Critical Medicines Alliance’s strategic report. The initiative aims to strengthen the resilience of the European healthcare system and reduce dependency on non-European suppliers.
Written assessment and approval of third-party audit reports by the QP
The EMA has published updated GMP Questions and Answers (Q&As). Two new questions address third-party audits:
- “Is a third-party audit acceptable?”
- “What are the expectations for the content of the written final assessment of third-party audit reports?”
Recommendation
Heidelberg, Germany10/11 February 2026
Combination Products
(See Questions 3 and 9 on the EU GMP Guide Part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances.) These Q&As were developed and endorsed by the GMDP Inspectors Working Group.
The answers provide a clear summary of current expectations and outline what a Qualified Person (QP) must consider when relying on audit reports from external auditors, including the requirement for a written final assessment and approval.
New Q&As on the QP Declaration published
Further to the Q&As on third-party audits, the EMA has published an additional Q&A document (EMA/129980/2025) clarifying how third-party audits should be reflected in Part C of the QP Declaration.
Part C is intended to provide information on audits relating to the manufacture of active substances. It applies to the manufacturing sites of active substances listed in Part A of the QP Declaration.
Revision of the GMP Guideline for ATMPs
On 08 May 2025, EMA published a Concept Paper proposing a revision to Part IV of the EU Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products (ATMPs). The currently valid version dates from November 2017. The public consultation on this Concept Paper ran from 08 May to 08 July 2025.
Facilitated recognition of FDA inspections
The EMA has updated its Questions and Answers document on the implications of the Mutual Recognition Agreement (MRA) between the European Union and the United States. A clarification was added concerning FDA inspections conducted outside the United States (Question 3).
The EU GMP/GDP Inspectors Working Group has agreed “to allow the voluntary application of the MRA provided for in Article 3(1) of the Agreement between the EU and the USA, enabling reliance on the results of FDA inspections conducted outside the United States from 01 October 2025.”
Additional adjustments reflect developments in the field of veterinary medicinal products.
Recommendation
17/18 February 2026
GMP meets AI - How to Use Artificial Intelligence in Quality Assurance and Quality Control - Live Online Training
FDA
More unannounced inspections, also outside the USA
The FDA has announced that it will now conduct unannounced inspections of companies outside the United States, mirroring its approach inside the USA. This decision follows a pilot programme carried out in India and China, and the first unannounced inspections have already taken place.
The FDA is also revising its procedures to avoid potential conflicts of interest. For example, inspectors will no longer accept travel assistance from companies (e.g., hotel bookings or transport).
Guidance on Remote Oversight Tools and Remote Assessments
In September 2023, the FDA issued a draft guidance on the potential use of alternative tools during inspection preparation or, in some cases, in lieu of an inspection for pending applications (Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications). The final guidance has now been published, incorporating feedback received on the draft.
The intention is to establish a risk-based approach to decision-making regarding requests for additional documentation, remote assessments, or the use of information from other authorities.
In addition, the FDA has published the Guidance for Industry: Conducting Remote Regulatory Assessments – Questions and Answers, describing how remote regulatory assessments (RRAs) will be used for FDA-regulated products. This final version is based on the revised draft issued in January 2024 and reflects stakeholders' comments.
Quality Management Maturity Programme continues
The FDA has announced the continuation of its voluntary Quality Management Maturity (QMM) Programme. The initiative aims to further enhance the evaluation of quality management practices.
Building on insights gained from earlier pilot activities, the programme introduces a streamlined assessment protocol focusing on critical elements such as supply planning, data management, and continual improvement.
Final version of the Advanced Manufacturing Technologies (AMT) Guideline
Early in 2024, the FDA published2 a draft guideline on promoting Advanced Manufacturing Technologies (AMT). AMT refers to innovative pharmaceutical manufacturing technologies or approaches with the potential to improve the reliability and robustness of manufacturing processes.
The final guideline has now been issued and includes several substantive clarifications and expansions compared with the draft, providing greater clarity.
ICH
Updated Q8/Q9/Q10 Questions & Answers Document
In early 2024, the ICH Secretariat announced the publication of a Q8/Q9/Q10 Questions and Answers (R5) document relating to ICH Q9(R1) Quality Risk Management (QRM). The ICH Assembly approved the document on 30 October 2024.
The Q&As were revised with minor additions to close content gaps and improve alignment with the implementation of ICH Q8, Q9, and Q10. Additional minor changes were made to improve the document’s readability.
ICH publishes Training Material for Q2(R2) and Q14
In July 2025, the ICH published training modules 1 to 7 for ICH Q2(R2) “Validation of Analytical Procedures” and ICH Q14 “Analytical Procedure Development”. The files are available for download on the ICH website.
PIC/S
Guidance Documents on Remote Assessments
PIC/S has published two guidance documents for inspectors:
- “Guidance on Remote Assessments” (PI 056-1)
- “Aide Memoire on Remote Assessments” (PI 057-1)
Both documents were prepared by the PIC/S Working Group on Remote Assessments.
The guidance documents provide direction on conducting and using remote assessments and aim to harmonise approaches across inspectorates. They address logistical considerations and technical requirements for performing such assessments.
EDQM
Supplement 11.8 to the European Pharmacopoeia
Supplement 11.8 to the European Pharmacopoeia (Ph. Eur.) has been published. All CEP (Certificate of Suitability) holders were required to align their specifications, and consequently their CEPs, with the revised monographs by 01 July 2025.
A table lists all substances subject to revised or updated monographs, including their classification (Case A or Case B).
The list of substances and further information on Supplement 11.8 are available on the EDQM website.
Update of CEP Guidelines
In May, EDQM published the first revision of the guideline “How to Read a CEP (PA/PH/CEP (15) 31, 1R)” on its website. The updates mainly reflect the introduction of CEP 2.0 in 2023. The three existing CEP formats (CEP 2.0, Hybrid CEP, and CEP) are clearly presented in the new version.
In early December 2025, the draft of the 8th revision of the Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs was published on the EDQM website under Newsroom: Certificate of Suitability and is available for public consultation until 16 January 2026.
Switzerland
Update of the Technical Interpretation for PQR
Changes are described in Chapter 5 of the newly issued Version 7.0. These include clarification of responsibilities for the preparation and assessment of the PQR between manufacturer and Marketing Authorisation Holder.
The interval for preparing a PQR when only a few batches were produced (or no production took place) has been reduced from five years to three years.
A completely new section, Chapter 4.6, covers parallel imported products.
About the Author
Wolfgang Schmitt is Vice President at CONCEPT HEIDELBERG and organises and conducts courses and conferences on behalf of the ECA Academy in the areas of GMP Systems and Compliance, Qualified Person and GMP Auditing. He is also Administration Manager of the European QP Association and Member of the Board of Directors of the European GMP Auditor Association.
Notes:
1 https://www.gmp-compliance.org/gmp-news/strategic-report-published-by-the-critical-medicines-alliance
2 https://www.fda.gov/media/174651/download
