GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice)

Japan's manufacturing and quality control standard for regenerative medical products, the PMD Act category that covers cellular and tissue-based products and gene therapy products. The legal text is the GCTP Ministerial Ordinance, MHLW Ordinance No. 93 of 2014, which PMDA describes in English as GMP for regenerative medical products. It plays the role for these products that the GMP Ministerial Ordinance plays for drugs. A foreign site that makes a regenerative medical product for Japan needs accreditation from the Minister, and PMDA examines whether the site conforms to GCTP. Japanese CPC and CDMO documents cite it whenever a product is regulated as a regenerative medical product rather than a drug.