- The Japanese MHLW has increased its budget by over $3 billion for fiscal year 2025. The extra funding will be used to enhance the development of promising drugs and medical devices. Part of the budget will be allocated to building a stronger base of Japanese talent in the biologics area, increasing the quality of GMP inspectors, adding more reviewers to the PMDA, etc. In addition, the PMDA will be more flexible with reviewing and responding to questions and documents submitted in English. Finally, instead of just opening an office in the US with one PMDA official to support US healthcare companies interested in the Japanese market, the budget will now include funds for 2 PMDA officers.
- For medical devices, the Chinese CMDE has sent out a draft announcement updating the list of devices exempt from clinical trials. In their draft proposal, an additional 23 devices will be added to the exempt list and there will be 20 revisions (product description, product name, etc.) to devices already on the exempt list. Feedback on this draft is suggested to be by early September. Please remember if a device is excluded from a local clinical trial in China, it will mean only a Clinical Evaluation Report (CER) is needed for device approval. The cost and time to put together a CER report versus a local Chinese clinical trial is significantly less.
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.
