Pharmaceutical products intended for the Japanese market shall comply with the Pharmaceuticals and Medical Devices Act (PMD Act). The PMD Act covers pharmaceuticals, quasi-drugs, cosmetics, medical devices, and regenerative medicine products.
For example, in the case of pharmaceuticals, there are several requirements for marketing authorisation in the Japanese market. Similar to other regions, the two main points are as follows and are stipulated in Article 14.
- Approved after a review of quality, efficacy, and safety
- Compliance of the manufacturing facility with GMP standards
Manufacturing facilities must comply with Japan's GMP (J-GMP) and adhere to the approved matters while conducting commercial production.
J-GMP is positioned as a Ministry of Health, Labour and Welfare (MHLW) ordinance linked to Article 14 of the Pharmaceuticals and Medical Devices Act.
As indicated in the linked resources (https://www.pmda.go.jp/files/000269146.pdf), J-GMP does not provide extensive details. To address this, a supplementary notification (No. 0428-2, April 28th 2021: Japanese version only) is issued, which serves as references for system development. Additionally, a collection of GMP case studies (“Jirei-shu 2022”: Jpanese version only) is available, functioning as a Q&A for J-GMP. While it is necessary to consider the Q&A as part of system development to address the points listed, strict adherence to the Q&A is not mandatory. Alternative methods may be acceptable as long as they provide equivalent or superior assurance.
Furthermore, since the PMDA is a member of PIC/S, there are instances where guidance is provided based on PIC/S GMP using a risk-based approach. Therefore, it is essential to consider this GMP framework when developing and operating your internal systems.
