European GMP Regulations: Ongoing Changes and What Lies Ahead

18.05.2026

LOGFILE Feature

Report from the 2026 ISPE European Annual Conference, 20-22 April 2026, Copenhagen

4 min. reading time | by Sabine Paris, PhD
Published in LOGFILE 10/2026

At the 2026 ISPE European Annual Conference in Copenhagen, Brendan Cuddy (EMA) provided a concise update on current European GMP regulatory developments and the work of the GMP/GDP Inspectors Working Group (GMDP IWG).

A clear message emerged: stakeholders strongly support the regulators’ direction of travel toward modernising EU GMP guidance. Significant numbers of comments were received during consultations – particularly for Chapter 4, Annex 11, and the new Annex 22 on AI.

Current Status of Key Documents

Publication is expected shortly:

Annex 19 (Reference and Retention Samples), update following the separation of veterinary GMP requirements in the new Implementing Regulations

Review of comments completed:

Chapter 4 (Documentation)
Annex 22 (Artificial Intelligence)
Part IV (ATMPs)

Review of comments ongoing:

Chapter 1 (Pharmaceutical Quality System):
Comment review has started.

Annex 11 (Computerised Systems):
The drafting group has already classified around 2,900 comments, with detailed review work now to follow. Finalisation of the review is expected over the summer.

Annex 3 (Radiopharmaceuticals):
Comment review is ongoing.

Annex 6 (Medicinal Gases) and Annex 15 (Qualification and Validation):
Consultations on the concept papers have recently closed. Review of comments is the next step.

Drafting is expected shortly:

Annex 14 (Plasma derived Medicines):
Update due to the SoHo Regulation 2024/1938 on substances of human origin

Supplementary Guidance planned for 2026:

Q&As on contamination control for non-sterile manufacturing
Q&As on decentralised manufacturing

Figure 1 | Current status of draft guidelines (Brendan Cuddy, 2026 ISPE European Annual Conference)

Annex 22 on Artificial Intelligence (AI): A Key Debate

One of the most significant themes raised in consultation was that the guidance should not categorically prohibit specific technologies such as Large Language Models (LLMs). Instead, many stakeholders support a risk-based approach, focusing on GMP criticality, intended use, controls, and oversight.

In response, EMA plans to hold an online expert workshop with stakeholder associations at the end of June 2026 to explore whether a risk-based framework, supported by appropriate guardrails, can adequately address the opportunities and risks of Generative AI in GMP environments.

Modernisation of EudraGMDP

Brendan pointed out that the objective is to improve performance of the data base, deliver user-focused capabilities, and transition to a modern platform.

A new user interface will allow a single global search across all types of documents.

User Acceptance Testing (UAT) for manufacturing authorisations and GMP certificates is planned for Q3 2026. UAT for the registration of APIs, wholesaler distribution authorisations and GDP is planned for Q4 2026.

GDP

An EU/EEA GDP Working Group has been established to work on:

a new procedure for dealing with serious non-compliance with GDP
a revision of the GDP inspection procedure to formalise the risk-based approach to GDP inspection planning
new guidance for wholesalers on performing risk assessment for the verification of the authenticity of medicinal products at risk of falsification

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de

Dr. Sabine Paris Published on 18 May 2026

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