Recommended Drug Development Strategy in Japan
Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) accept global clinical data by bridging strategy and global simultaneous development strategies since 2007. Recently many innovative products including cell therapies and gene therapies have been developed with global simultaneous development strategies. The global simultaneous development strategy is suitable and effective pathway to get regulatory approvals in Japan. Key points for global development strategies are
・ Safety confirmation with Japanese subject
・ PMDA consultation before Global Phase III
・ Global phase III study
・ 15-10% Japanese patients of Global sample size
In addition, MHLW and PMDA issued innovative drug development regulation, SAKIGAKE designation and Early Conditional approval. MHLW and PMDA are becoming more open to accelerate innovative product development to help patients in Japan
