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The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.
On Oct. 20, 2017, the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA) published a joint action plan to help further the development of advanced therapy medicinal products (ATMPs). The plan includes new guidelines, training sessions, and harmonization efforts, which will help streamline procedures and address requirements and challenges associated with these products.
The plan, developed in association with European Member States, includes 19 actions that address early interaction, information sharing, harmonization between Member States, and problems with patient access. A GMP guideline will address manufacturing requirements for ATMPs. Other guidelines will clarify regulatory expectations on ATMPs and investigational ATMPs. Training sessions will also be organized by EMA.
ATMPs are developed using genes or cells and are often ground-breaking treatments for severe, untreatable, or chronic diseases that do not have conventional treatment options. Nine such products have been approved in Europe since ATMP regulations were adopted in 2009, and 18 marketing authorization applications have been received by EMA. International regulatory agencies, including FDA, Health Canada, and the Japanese Pharmaceuticals and Medical Devices Agency, have worked together to share their ATMP experiences in order to foster the development of these products.