Revisions will guarantee high-quality standards of advanced therapy medicinal products (ATMPs) and provide patient protection.
The European Commission has issued guidelines on good manufacturing practice requirements specific to ATMPs. ATMPs are medicines which act on a cellular or genetic level. ATMPs offer innovative treatment opportunities especially in case of incurable diseases, severe injuries or chronic illnesses which can’t be treated with standard therapies.
The new guidelines contain the European Union GMP demands on exact features of ATMPs as well as requirements for manufacturing procedures. The guidelines are made in accordance with a risk-based approach to production and approbation of these products. The guidelines also guarantee that ATMPs are regularly manufactured and the manufacturing process is controlled in concordance with standards of high quality to ensure benefit and safety for patients. This endeavor is a part of collaborative efforts of Directorate General for Health and Food Safety and the European Medicines Agency (EMA) to stimulate the development of ATMPs.