The Regulatory Pulse for Advanced Therapies

Advanced therapies such as cell and gene therapies and regenerative medicine offer ground-breaking treatment for many diseases that could not be adequately treated previously. In the European Union, for example, advanced therapies for conditions such as prostate cancer and cartilage regeneration have been recently approved. Regulations governing these products, however, vary greatly by health authorities across the globe. Gopalan Narayanan, MD, Biologics and Advanced Therapies Expert at UK-based NDA Group, is chairing a session related to this topic at DIA’s upcoming 51st Annual Meeting in Washington, where speakers will examine the regulatory requirements and classification issues specific to advanced therapy products.

Narayanan recently shared his thoughts with Pharm Exec on the regulatory environment today in Europe and elsewhere for advanced therapies, the progress in advancing regulatory science for these products, and the struggle, at the same time, in translating that to more approved treatments in this area. He also comments on the conditional marketing approval experiment underway in one country and its potential implications.