The PIC/S raised concerns about the plan in a letter published Last week, arguing separate more flexible good manufacturing practice (GMP) rules that take the variability involved in making cell and gene therapies into account would put patient safety at risk.
The Commission rejected this idea, telling us “During the drafting of the Guidelines of Good Manufacturing Practice for ATMPs, particular attention has been paid to ensuring that the adaptations introduced in the GMP framework for ATMPs are compatible with a high level of quality for ATMPs and a high level of patient's protection."
It also contested the PIC/S’ other suggestion that separate rules would hinder efforts to harmonize GMP, arguing instead that there is a lack of regulation of advanced therapy medicinal products (ATMP).
“The suggestion that the EU would be applying standards lower than PIC/s is not consistent with the fact that certain PIC/s members do not even regulate ATMPs as medicinal products, and that -in other PIC/s countries- certain categories of ATMPs are not covered under the medicinal products framework."
The European Commission also reiterated its view that flexible GMP would facilitate development of cell and gene therapy products.
“The development of a specific GMP framework is necessary to facilitate the development of these innovative products for the benefit of patients, including also by increasing opportunities of patients to enrol in clinical trials conducted inside the EU.”
It added that: “Once the Guidelines on Good Manufacturing Practice specific for ATMPs are adopted, references to ATMPs in Annex 2 will become obsolete and the necessary changes should be made to the Annex with a view to ensuring legal certainty for manufacturers of ATMPs.
“In turn, the repeal of Annex 13 is linked to the requirement in the new Regulation on clinical trials that the principles and guidelines on good manufacturing practice should be adopted in the form of a delegated act.”