In-country testing of Advanced Therapy Medicinal Products
Advanced Therapy Medicinal Products (ATMPs) are medicines based on cells, genes or tissues.
They offer ground-breaking new opportunities for the treatment of disease and injury. Regulatory requirements have not kept the same pace as advancements in ATMP innovation. As a consequence, ATMPs are regulated in various manners in international markets and in many cases lack specific regulation
Existing in-country testing requirements for traditional biological products may be applied without acknowledging the specific considerations for these new therapies.
This paper discusses specifics of ATMPs, where traditional in-country testing is challenging, outlining existing control strategies to detect potential issues, with recommendations to waive in-country testing without compromising product safety, quality and efficacy and in compliance with requirements, i.e., by recognition of certificates from countries with mature National Regulatory Authorities (NRAs).