ATMPs are medicines for human use that are based on genes or cells. These therapies 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. The guidelines ensure that these novel medicinal products are consistently produced and controlled according to high quality standards, for the benefit and the safety of patients. This initiative is part of the joint action plan launched by the Directorate General for Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA) in October 2017 to foster the development of ATMPs.
The European Commission drafted these guidelines with extensive input from the Agency’s Committee for Advanced Therapies and GMP/Good distribution parctice inspectors working group, together with national competent authorities and other external stakeholders.