Regulations of the Advanced Therapy Medicinal Products (ATMPs) in the EU

9:45 AM - 10:25 AM

ATMPs are novel Cell and Gene Therapy Products that offer new treatment options for rare diseases and for patients with unmet medical need. While ATMPs hold high promise and some of them have shown excellent efficacy, they have very different safety issues from traditional drugs and often pose high risks to the patients. Furthermore, the nature of ATMPs is unique, thus requiring its own legal and regulatory framework with specific guidance. In the EU, the Committee of Advanced Therapies (CAT) under the European Medicines Agency (EMA) is responsible for the review of Marketing Authorisation Applications (MAA) of ATMPs.