Spurred by the harmonization of safety requirements on drug development by regulators in the United States and Europe, Japan’s drug regulators are tightening requirements on the development of new pharmaceuticals.
By next year, for example, all products used in clinical trials must be reported to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The new mandate is designed to improve the safety of clinical trial processes and to provide a way to monitor and supervise trials more evenly. It applies to all products used in trials, even those not manufactured by the company doing the research or that are not the focus of the trial.
The PMDA is also strongly considering new ways to utilize artificial intelligence technologies to integrate quality and safety systems with regulatory intelligence databases and product information. But such synchronization is still in the exploratory stages.
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.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/regulatory-guideline-for-3d-printed-medical-devices.pdf