During the last year, we have outlined the steps the PMDA is taking to expedite registration for Software as a Medical Device (SaMD). Besides expanding its SaMD review staff and offering more SaMD consultation sessions, the PMDA presented on January 22nd in its 5th year plan (2024- 2028) its goal that all SaMD products will receive a priority passageway for registration. SaMD registration reviews will now be completed within six months.
For drugs, the PMDA also hopes to expedite approvals, especially for innovative products. To do this, the PMDA will offer more consultation services for innovative drugs to ensure “efficient and quality reviews”. To help stimulate the availability of innovative drugs in Japan, the PMDA will now provide earlier feedback on initial applications even when required data is not complete. During these early preliminary reviews, the PMDA will also help applicants determine clinical assessment guidelines sooner. In addition, the PMDA plans to bolster its support for pediatric, orphan, and emergency drugs.
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/