Publication of a Paper Comparing the Environmental Impact Assessment of AAV Gene Therapy in Japan and Europe
July 24, 2024
The JPMA (Regulatory Affairs Committee and Biopharmaceutical 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 the AAV 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 in Japan.
The published paper can be found at the following link.
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The five Cartagena organizations areThe Cartagena 5 Organizations are the Pharmaceutical Research and Manufacturers Association (PhRMA), JPMA (Regulatory Affairs Committee and Biopharmaceutical Committee), European Federation of Pharmaceutical Industries and Associations (EFPIA), Japan Biotech Council, and Forum for Innovation in Regenerative Medicine (FIRM), which are working to improve the Cartagena Act procedures for gene therapy development. 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.