GMP Regulations Report 2025
2 Min. Lesezeit | by Dr. Sabine Paris
What do the regulatory developments mean for your professional environment? Which requirements have a direct impact on your day-to-day work, and where is there an urgent need for action? Our GMP Regulations Report 2025 provides a clear structure, practical explanations, and the most important regulatory developments of 2025 – concise, well-organized, and relevant.
2025 was a year marked by important regulatory developments and a wide range of topics. Once again, nitrosamine impurities were at the center of attention. The EMA published multiple updates on this issue, including numerous new acceptable intake values, clarifications in the Q&As, and a joint report by the EMA and the CMDh. In addition, other authorities and organizations such as Swissmedic, the FDA, the WHO, IPEC, and APIC intensified their ac-tivities related to the risk assessment and control of nitrosamines.
For the first time in quite a while, there were significant updates to the EU GMP Guide. The European Commission published revised versions of key GMP documents, including Chapter 1, Chapter 4, Annex 11, and, for the first time, the new Annex 22 on Artificial Intelligence. In parallel, the EMA initiated the revision of GMP Part IV for ATMPs.
The reform of the EU pharmaceutical legislation also continued to progress. Council positions on data and market protection, exclusivities, supply obligations, and the promotion of generics were published. In December, the European Commission, the European Parliament, and the Council of the European Union reached a provisional agreement on updating the legal framework for medicinal products in Europe. In addition, a proposal for a new regulation on critical medicines was presented with the aim of strengthening security of supply and production capacities.
At the international level, the WHO published several new GMP-relevant annexes (TRS 1060), while ISO and DIN released updates related to cleanrooms. The ICH published a comprehensively updated version of the ICH Q1 guideline on stability testing, as well as a draft version of the ICH Q3E guideline on extractables and leachables for consultation.
In the field of medical devices, key topics in 2025 included the parallel application of the MDR/IVDR and the new AI Act, the targeted revision of the Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR), and the FDA guidance on Computer Software Assurance (CSA). Furthermore, industry stakeholders called for adjustments to horizontal digital legislation to improve compatibility with medical device law.
Table of contents of our Regulations Report 2025:
This is a brief overview of the GMP topics for 2025. You can request the full GMP Regulations Report 2025 here.
Do you have any questions or suggestions? Please contact us at:redaktion@gmp-verlag.de
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