ATMP Action Plan ATMPs

The european commission's directorate-general for health and food safety (DG Sante) and the european medicines agency (EMA) in collaboration with the member states competent authorities published a joint action plan to foster the development and authorization of advanced therapy medicinal products (ATMPs). The main aim is to streamline procedures and better address the specific requirements of ATMP developers. The plan published contains 19 actions in different areas, some already in place and others new.

Examples of upcoming actions include:

• European commission guideline on good manufacturing practice for ATMPs, to reduce the administrative burden and adapt the manufacturing requirements to the specific characteristics of ATMPs
• New EMA scientific guidelines on ATMPs, including investigational ATMPs, to clarify regulatory expectations

For more information about the new action plan for ATMPs look at the publication of the EMA.

Find out also about our services on the subject of GMP for ATMPs