Publication of a Paper Comparing the Environmental Impact Assessment of AAV Gene Therapy in Japan and Europe
July 24, 2024
The Pharmaceutical Manufacturers Association of Japan (Pharmaceutical Affairs Committee and Biopharmaceuticals Committee) is acting as a Cartagena 5 organization*. The Cartagena 5 Organizations have published a paper that provides a detailed comparative analysis of the requirements under the Japanese and European environmental impact assessment regulations (Cartagena Act vs. European Directive) for the development of AAV gene therapies. The paper revealed that while some information is required only in Japan or only in Europe, there is no significant difference in the way it is used in clinical practice. Based on these results, we will continue discussions with the regulatory authorities regarding the simplification of the materials and procedures to be submitted at the time of application for Type I Cartagena Act in Japan.
The published paper can be found at the following link.
-
The five Cartagena organizations areThe five Cartagena organizations are the Pharmaceutical Research and Manufacturers of America (PhRMA), the Pharmaceutical Manufacturers Association of Japan (Pharmaceutical Affairs Committee, Biopharmaceutical Committee), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japan Biotechnology Council, and the Forum for Innovation in Regenerative Medicine (FIRM). The goal of the FIRM is to improve the procedures of the Cartagena Act in the development of gene therapies and to increase Japan's international competitiveness.