Pharmaceuticals and Medical Devices Agency

Pharmaceuticals and Medical Devices Agency
独立行政法人医薬品医療機器総合機構
Agency overview
Formed	1 April 2004; 21 years ago
Employees	873[citation needed]
Website	www.pmda.go.jp

The Pharmaceuticals and Medical Devices Agency (独立行政法人医薬品医療機器総合機構) (PMDA) is a Japanese corporation, an Independent Administrative Institution, responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan.^[1]^{[better source needed]} It is similar in function, in many respects, to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Spanish Agency of Medicines and Medical Devices in Spain or the Food and Drug Administration in the Philippines.^[2]

The PMDA has been eCTD-compliant^{[clarification needed]} at least since July 2017.^[3]^{[non-primary source needed]}^{[better source needed]}

Tasks

Among other things, the agency is tasked with the following:

Drug and medical device testing:^{[citation needed]}
- Scientific review of market authorization applications based on Japanese pharmaceutical law
- Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA))
- Inspection and conformity assessment of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Practice Systems and Programs (GPSP)
- Auditing of manufacturers to ensure they conform to Good Manufacturing Practice (GMP) and have a suitable Quality Management System (QMS)
Post-marketing drug safety:^{[citation needed]}
- The collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices
- Advising consumers on approved products
- Research on the development of industry standards
Victim compensation:^{[citation needed]}
- Payment of medical costs, lost wages, and pain and suffering for those who experience injury or disability resulting from the use of medical products
- Disbursement of funds to those infected with HIV as a result of blood transfusions

Leadership

As of this date, ^[when?] he chief executive of the agency is Yasuhiro Fujiwara, former head of the National Cancer Center Japan.^{[citation needed]} From 2008 to 2018, the chief executive of the agency was Tatsuya Kondo, a neurosurgeon and graduate of the University of Tokyo.^{[citation needed]}

References

^ Qualtech Staff (2020-08-07). "Japan PMDA". Qualtechs.com. Taipei City, Taiwan: Qualtech. Archived from the original (commercial, promotional CRO webpage) on 2020-08-07. Retrieved 2025-02-25.^{[better source needed]}
^ Nagasaka, Satoru; Lang, Benjamin; Shintani, Mihoko & Ueno, Sayaka (April 2008). "An Overview of Pharmaceutical and Medical Device Regulation in Japan" (PDF). Asian Counsel. Philadelphia, PA: Morgan Lewis-TMI: 28–31. Archived from the original (PDF) on 11 February 2014. Retrieved 30 September 2012. Morgan Lewis-TMI is a joint venture between Morgan, Lewis & Bockius LLP and TMI Associates [Tokyo, Japan].{{cite journal}}: CS1 maint: multiple names: authors list (link)
^ PMDA Staff (December 2017) [July 2017]. "Appendix 1: ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide in Japan v1.2.0" (technical implementation guide, PDF format). PMDA.go.jp. pp. 1–95. Retrieved 2025-02-25. This document describes handling of Appendix 3 "ICH electronic common technical document (eCTD) v4.0 Implementation guide v1.2" (hereinafter referred to as "ICH IG") in Japan upon implementing eCTD.^{[page needed]}