As reported over the last year or so, Japan is trying to fix its drug loss problem, where many drugs approved in the US and EU are still not approved in Japan. Based on past drug approvals in the West, from 2016 to 2020, Japan is now focusing on 78 specific drugs that are not yet available in Japan. For these drugs, a special health sciences group has allocated four categories for Japan to prioritize. Group A, with 14 drugs, is the highest in demand for development. Group B, with 41 drugs, is the second highest in need for development. Group C, with 11 drugs, is considered a low priority, and Group D, with 12 drugs, is now described as not needed for development.
Included in the 14 Group A drugs are drugs focused on metastatic GIST, malaria, facial and truncal acne, community-based bacterial pneumonia, etc. Next, the special health sciences group will look at the 41 Group B drugs, and this work will be funded by Japan’s supplementary budget for FY2024. In addition, the FY2024 budget will help look at new products approved in the US or EU but not yet in Japan during the next time period from January 1, 2021, through March 31, 2023 – and perform the same drug loss analysis as used in the previous time period to determine the first 78 drug loss products. This work will be done by the Mitsubishi Research Institute. By doing periodic Japan drug loss work, Japan hopes to ensure its patients receive all the drugs available to patients in the West.
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.