As mentioned in our newsletter over the last 18 months, Japan is now taking a more aggressive posture to tackle the issue that many drugs in the West are not yet available in Japan. To help speed up the process, the MHLW has established programs for more Japanese companies to be in touch with foreign companies for partnership opportunities. In addition, the MHLW is setting up new programs for Western companies with drugs in high demand to focus more on the Japanese market.
The MHLW’s council on Unapproved Drugs and Indications With Unmet Medical Needs will now implement several programs. First, on May 9, the MHLW announced that it would solicit Western drug companies and offer a subsidy to specific Western drug companies interested in entering the Japanese market. The MHLW will support several organizations, including JETRO (the Japanese trade group), the Health Research Promotion Bureau, PMDA regulatory professionals, and others – in solicitation of Western drug companies with needed drugs. To help incentivize Western companies, the MHLW will waive some of the fees for PMDA consultation meetings, conduct meetings overseas in English, build a research team to seek infectious disease remedies, etc. The MHLW’s main target will be Western biotech companies with drugs in demand that have not considered entering Japan yet.
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.