The European Medicines Agency (EMA) has proposed a revision to GMP guidelines for ATMPs to remove ambiguity and inconsistencies.
EU GMP guidelines are a part of Eudralex Volume 4, which is the collection of EU pharmaceutical legislation.
Volume 4 contains four Parts and 23 Annexes.
Part IV, adopted in 2017, lays out specific requirements for ATMPs.
An ATMP, or Advanced Therapy Medicinal Product, is a medicinal product that uses genes, cells, or tissues to treat, prevent, or cure diseases.
The biological nature of these products required a markedly different production approach to traditional pharmaceuticals, necessitating the separate Part.
Since the major revision of Annex 1 in 2023, which governs sterile pharmaceutical products, there has been some concern about Part IV being outdated.
The draft guideline is provisionally scheduled for release in September 2026, with full adoption expected by March 2027
The new proposal from the EMA would suggest updating the Part to fall in line with the Annex 1 updated standards.
The proposal states that the current Part does not have up-to-date guidelines on using Quality Risk Management (QRM) and Contamination Control Strategy (CCS) concepts, as detailed in Annex 1.
The proposal also indicates that many recent technological developments are not reflected in Part IV yet, and as ATMPs are an innovative area, this is a glaring shortcoming to its mission.
The proposal stated that a revision will "embrace the use of new technologies that are not currently covered in the current version (e.g. automated advanced technology, (closed) single use systems, and fast, rapid microbiological testing methods)".
The proposal also points to barrier system guidelines as a big technological oversight, stating: "The [new Part IV] will give further clarifications on the expectations [on] how to qualify, control and manage clean rooms and closed systems (isolators and Restricted Access Barriers Systems (RABS)) in order to prevent detrimental impact on product but it will [also remain] open to the use of biosafety cabinets due to of the numerous manual manipulations associated with the individualised batches."
What next?
The proposal is now up for public consultation, with a deadline for comments of 8th July.
The draft guideline is provisionally scheduled for release in September 2026, with full adoption expected by March 2027.