Over the last year or so, we have reported on the many ways the Japanese government has tried to reduce Japan’s drug loss. So many drugs are approved in the West but not yet available in Japan. Such measures have included a revised conditional approval scheme, the acceptance of innovative drug applications in English (not Japanese), the opening of the PMDA offices in Thailand and now Washington, DC, etc. Under the new PMDA scheme, instead of waiting for scientific societies or various patient advocacy groups to determine which drugs are most needed in Japan, the MHLW will take the first steps to do so. The Japanese Pharmaceutical Manufacturing Association (JPMA) identified 86 key drugs in 2023 that Japan needs right away. Since then, 8 of these drugs have been dealt with, so now the focus is on the remaining 78. The Japan Association of Medical Sciences, under the MHLW direction, will now confirm evidence of these 78 drugs for efficacy and safety. This list is based on drugs approved in the US and EU from 2016 to 2020 and focuses mainly on biotech, pediatric, and rare disease drugs.
The MHLW will outline the drug shortage findings of the Council on Unapproved Drugs and Indications with Unmet Medical Needs to both domestic and foreign drug suppliers. The MHLW will also prioritize which of the top 78 drugs they want to focus on first and solicit sponsors to step up to meet the urgent demand. This new program will be designated in the 2025 budget and will be started in the next fiscal year. In addition, since the survey was completed in 2023, new drugs in high demand since then will also be added too.
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.