Advanced Therapy Medicinal Products (ATMPs) are medicines based on cells, genes or tissues.<\/p>\n
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<\/p>\n
Existing in-country testing requirements for traditional biological products may be applied without acknowledging the specific considerations for these new therapies.<\/p>\n
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).<\/p>\n","protected":false},"excerpt":{"rendered":"
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).<\/p>\n","protected":false},"featured_media":10003,"template":"","publication_type":[7],"topic":[26,14],"class_list":["post-9431","publications","type-publications","status-publish","has-post-thumbnail","hentry","publication_type-position-paper","topic-regulatory-convergence-and-reliance","topic-trade"],"acf":[],"yoast_head":"\n