Proposed Revision of EU GMP Part IV, ATMPs

Date

May 13, 2025

Category

EU Regulations

Description

On 8 May 2025 the EMA issued a Concept Paper proposing a revision Eudralex volume 4, Part IV, GMP specific to Advanced Therapy Medicinal Products (ATMPs). Comments to be submitted by 8 July 2025.

The revision is being proposed as Part IV is written to be a stand alone GMP for ATMPs, which has no references to the remainer of the EU GMPs. This means that changes to the remaining GMPs, such as the revision of Annex 1, the incorporation of the concepts contained in ICH Q9 and Q10, etc. are not reflected in Part IV.

This revision would be largely unnecessary if the EU had adopted the PIC/S approach and added the specific requirements for ATMP GMP as Annex 2a, which explicitly states that the remainder of the GMPs do apply.

The Concept Paper can be found at ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-part-iv-guidelines-good-manufacturing-practice-specific-advanced-therapy-medicinal-products_en.pdf