For regenerative medicine, the applicable legal regulations differ based on whether the products are distributed by a company as regenerative medicine products or offered as medical services (Regenerative Medicine Technology) within medical institutions.
In the former case, the products are regulated under the Pharmaceutical and Medical Device Act (PMD Act, No. 145) and must comply with the GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice) Ministerial Ordinance for manufacturing facilities. Notification No. 1009-1 supplements the GCTP.
In the latter case, activities are governed by the Act on Ensuring the Safety of Regenerative Medicine (Act No. 85), which regulates clinical research and private medical practices (i.e., non-insured medical care) conducted under its framework. Facilities providing this regenerative medicine technology are exempt from the GCTP Ministerial Ordinance. However, the requirements for such facilities are stipulated in Articles 91 to 110 of the Ministerial Ordinance No. 110, which supplements ACT No. 85 and are similar to the GCTP Ministerial Ordinance. Based on my experience, the initial inspection for facility registration focuses solely on the building. However, from the second inspection onward (during renewal), operational aspects may also be checked.
- PMD Act: https://laws.e-gov.go.jp/law/335AC0000000145
- Notification No. 1009-1: https://www.mhlw.go.jp/file/06-Seisakujouhou-11120000-Iyakushokuhinkyoku/0000061168.pdf
- Act No. 85: https://laws.e-gov.go.jp/law/425AC0000000085
- Ministerial Ordinance No. 110: https://laws.e-gov.go.jp/law/426M60000100110#Mp-Ch_4-At_100
