Japan’s MHLW is again proposing to add to the PMD Act the possibility of using real-world clinical data (RWD) for drug approvals. To date, drug approval in Japan has required randomized controlled Trials (RCT). This program was announced by the House Sciences Council subcommittee for medical devices and drugs. During this discussion, some members voiced concern that using only RWD would not be sufficient for drug approval. In response, another House member said maybe it is only best to use RWD in conjunction with RCT. Further discussion is expected in the coming months. While RWD has become more popular in the West, it is still in the process stage in Japan. In another update, the MHLW has relaxed its requirements for combination drugs. In the past, even if both drugs were approved independently, they still had to undergo approval with a new indication. This will no longer be a requirement and match policies in the US and EU.
Also, to attract more orphan and pediatric drugs to Japan, the PMDA has reduced regulatory consultation fees for drug development. The reduced fees started on July 1 and will last until early January 2025. Fees for consultations will be reduced between 50% and 100%. The Japanese government is hoping to start development plans, between 2024 and 2028, for 50 new pediatric drugs and 150 orphan drugs. Finally, the Japanese Diet advanced a bill to revise regenerative medicine. For regenerative medicine, their definition will now include some gene therapies. In addition, there will now be more emphasis on on-site audits of regenerative facilities.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.