The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach.
An ATMP’s risks depend on the product’s biological characteristics and the properties of non-cellular components such as raw materials. Manufacturers must use current scientific knowledge and experience when evaluating the risks and their mitigation strategies. In some cases, risk management strategies may be based on internal processes or empirical tools if these are more appropriate for the specific risks.
ATMP manufacturers also should apply a risk-based approach to their raw materials and should verify with their suppliers that all materials comply with agreed-upon specifications and all specifications should be re-assessed during the development and post-authorization processes to ensure any necessary updates are made. The new guidelines are effective May 22, 2018.
Earlier this year the European Medicines Agency found that lack of concrete guidance for ATMPs was a major obstacle to approvals for such products.
In October, the agency issued an action plan for improving ATMP development procedures.