According to the European Commission, the 90-page document shall facilitate the development and authorisation of these products as they offer ground-breaking new opportunities for the treatment of diseases and injuries. They are particularly important for severe, untreatable or chronic diseases for which conventional approaches have proven to be inadequate.
The new guidelines adapt the European Union GMP requirements to the specific characteristics of ATMPs and address the novel and complex manufacturing scenarios utilised for these products. The guidelines foster a risk-based approach to manufacture and testing of such products. They shall ensure that these novel medicinal products are consistently produced and controlled according to high-quality standards, for the benefit and the safety of patients.
Drafting the guidelines is part of the joint action plan initiated by the DG SANTE. The plan also includes a list of further actions for the time coming, e. g., the organisation of specific training to inspectors to achieve more harmonisation and increase the exchange of information within the network.
The guidelines were drafted with input from the Committee for Advanced Therapies (CAT), the GMP/GDP inspectors working group, national competent authorities and other external stakeholders. It is particularly emphasised that the guidelines are specific to ATMPs. Other documents developing GMP requirements for medicinal products which are contained in Eudralex Vol 4 are not applicable to AMPs, unless specific reference thereto is made. There was strong criticism from the PIC/S and its members on the stand-alone ATMP-Guidelines (we reported). In an open letter PIC/S has criticised the content of the ATMP GMP Guidelines to not only lower GMP standards for ATMP at the risk of patients but also to lead to an internationally non-harmonised approach to the implementation of GMP for ATMPs. We will keep you posted on any further comments that will be published.