Regulation of Cell and Gene Therapies – Part 2: EU Law

In May 2022, we discussed the U.S. approach and considerations important to regulation of tissues and cell-derived products. For this next roundtable, we will move to Europe and discuss the interplay between, on the one hand, the EU legislation on Advanced Therapy Medicinal Products (ATMPs) and, on another hand, the legislation on Blood and Blood Components and Tissues and Cells (BTC). This interplay raises a number of complex legal questions which are of specific interest for companies developing cell-, gene-, and tissue-derived medicinal products and are increasing in importance in light of the forthcoming revision of the EU legislation on blood, tissues and cells. The proposal for the new EU Regulation on SoHO (Substances of Human Origin) was published on July 14, 2022.

Our presentation will provide an overview of the regulatory frameworks, explain the key concepts for analyzing their interactions, and examine the existing challenges that the revision of the EU legislation on blood, tissues and cells and the Pharmaceutical Strategy for Europe expect to resolve.

For questions, contact Chayako Williams at cbwilliams@kslaw.com.