On March 1, the Japanese cabinet issued a draft bill which creates an emergency approval system for devices and drugs. The draft will make it easier for these medical products to receive approvals based on presumed efficacy if there is an emergency. For such products, there will be increased leniency with respect to notifications, labeling, GMP requirements, etc. Products with emergency approvals would only be allowed for a maximum of 2 years. Despite this quick process in Japan, these products eventually will need to confirm safety similar to other products being evaluated. The draft is now awaiting final approval.
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/files/000250259.pdf