Paper Published Comparing Environmental Impact Assessments of AAV Gene Therapy in Japan and Europe
July 24, 2024
The JPMA (Regulatory Affairs Committee, Biopharmaceutical Committee) operates as the Cartagena 5 Group *.The Cartagena 5 Group has recently published a paper presenting a detailed comparative analysis of the requirements mandated by environmental impact assessment regulations in Japan and Europe (the Cartagena Act vs. the European Directive) regarding the development of AAV gene therapy.This paper revealed that while certain information is required only in Japan or only in Europe, there are no significant differences in how these therapies are used in clinical practice. Moving forward, based on these results, we will continue to engage in discussions with regulatory authorities regarding the simplification of documentation and procedures required for Type 1 applications under Japan’s Cartagena Act.
The published paper can be viewed via the link below.
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*The “Cartagena 5” consortium consists of five organizations: the Pharmaceutical Research and Manufacturers of America (PhRMA), the Japan Pharmaceutical Manufacturers Association (JPMA; Regulatory Affairs Committee and 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 group works to improve procedures under the Cartagena Act for gene therapy development and enhance Japan’s international competitiveness.