On June 16, the PMDA steering committee announced that in April 2024 or shortly thereafter, the PMDA will open offices in the US and Southeast Asia. Likely locations for these offices are Washington DC and Bangkok, Thailand – although this is not finalized yet. Each overseas PMDA office will have 1-2 PMDA government officials plus some local hires too. Overall, the objective will be to expand relationships with local regulatory agencies and other local life science players.
The goal of the US PMDA branch office will be to improve access to new US-developing medical devices and drug companies – which may be interested in Japan. Japan is trying to welcome more new US medical technologies that can improve healthcare in Japan and reduce overall government spending costs. In addition, the US PMDA office will be closely tied to the US FDA for regulatory information sharing. The Southeast Asian office will help facilitate Japanese companies wanting to expand into ASEAN as well as support several Japanese organizations in the region – like the Japanese National Cancer Center and their clinical trial plans in the region.
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.
Source used in the article: https://www.pmda.go.jp/english/