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