- On July 18, the Japanese Ministry of Health, Labor and Welfare (MHLW) introduced new criteria for excluding certain drugs from mandatory post-marketing surveillance (PMS), traditionally required for newly approved medicines. This initiative aims to mitigate delays and reduce losses in drug availability. The MHLW informed the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) that PMS will not be mandatory if sufficient safety data from international clinical trials exist, as long as ethnic differences do not impact safety, or if adequate safety data from similar drugs with the same mechanism is available. Additionally, drugs with new indications or dosages may be exempt from PMS if sufficient safety data is already available, and no safety profile differences are anticipated.
- To expedite the availability of new medical devices, India is contemplating removing the clinical investigation requirement for devices approved by the European Union (EU). Currently, devices approved by the US, UK, Australia, Canada, and Japan are already exempt from this requirement. The proposal to include the EU will be discussed at the next Drugs Technical Authority Board (DTAB) meeting. If approved, Rule 63(1) of the Medical Devices Rules, 2017, will be amended.
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.
