Last month, one of our news briefs discussed remote inspections for medical device GCP. Recently, the PMDA also issued remote GCP inspections for drugs and regenerative products. In August, the Japanese PMDA issued these guidelines in English. These guidelines advise on the new policies of remote inspections, issues related to cloud usage, electronic submissions via the Gateway system, etc. To learn more, please refer to this official document: https://www.pmda.go.jp/files/000247966.pdf
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.gmp-compliance.org/gmp-news/pmda-publishes-remote-inspection-guidance