EMA releases concept paper to revise GMP Guidelines for ATMPs

June 10, 2025Dr. Sangeetha Iyer

Aligning with Annex 1 and Embracing Innovation in Sterile Manufacturing

On 8 May 2025, the European Medicines Agency (EMA) released a Concept Paper to revise Part IV of the GMP guidelines, specifically focused on Advanced Therapy Medicinal Products (ATMPs). ATMPs – which include gene therapies (incl. mRNA vaccines), somatic cell therapies, and tissue-engineered products – are highly innovative medicines designed for individualized treatment and often involve complex, manual, and small-scale manufacturing processes. Because of this unique nature, they require their own dedicated GMP guidelines that are more flexible than those for traditional pharmaceuticals.

This revision follows the implementation of the updated Annex 1 of EudraLex Volume 4 in August 2023 and aims to align Part IV with the latest standards while maintaining the adaptability needed for ATMP production.

Here’s a quick rundown of what this means and what’s coming:

Why the Update?

The current ATMP guideline was written before the updated Annex 1 and doesn’t include:
- Quality frameworks like ICH Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System)
- The Contamination Control Strategy (CCS)
- Advanced technologies such as closed systems and rapid testing methods

Key Proposed Changes

Stronger emphasis on Quality Risk Management using ICH Q9 principles.
Integration of a modern PQS (Pharmaceutical Quality System) approach as per ICH Q10.
Contamination Control Strategy (CCS) will be a key feature including:
- Cleanroom qualification and control
- Use of closed systems (e.g., isolators, Restricted Access Barriers Systems (RABS)).
Embrace of new manufacturing technologies:
- Automated, closed, single-use systems
- Rapid microbiological testing methods
Legal references and definitions will be updated, especially for human-derived starting materials following the new EU regulation ((EU) 2024/1938).
The current revision will only focus on the sterile manufacture sections related to the updated version of the Annex 1

Expected Impact

The proposed guideline will replace: ‘EudraLex Volume 4: Part IV GMP specific to ATMP
No major resource burden anticipated for industry
Clarified guidance may prompt gradual updates to facilities and equipment
Overall, this should lead to more consistent and higher-quality ATMP manufacturing across the EU

Bottom Line

This upcoming revision is a much-needed modernization of ATMP GMPs. It’s a positive step toward greater clarity, quality, and innovation in the fast-evolving field of advanced therapies. Read the full Concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.

Stay tuned as the consultation unfolds and if you’re a stakeholder, submit your feedback by 8 July 2025.

For a comprehensive overview of all regulations related to ATMPs, be sure to check out our detailed article here.