Pharmaceuticals and Medical Devices Agency

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Pharmaceuticals and Medical Devices Agency
独立行政法人医薬品医療機器総合機構
Dokuritsu-gyōsei hōjin iyakuhin-iryō-kiki-sōgō-kikō
Agency overview
Formed1 April 2004; 22 years ago (2004-04-01)
Employees873[citation needed]
Websitewww.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][2][better source needed] It is similar in function, in many respects, to the Food and Drug Administration in the United States,[3] 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.[4]

The PMDA adopted the International Council for Harmonisation (ICH) Electronic Common Technical Document (eCTD) format for electronic regulatory submissions beginning in 2017.[5][6][better source needed]

Tasks

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

  • Drug and medical device testing:[7][citation needed]
  • 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:[8][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

Yasuhiro Fujiwara, former head of the National Cancer Center Japan, became chief executive of the agency in April 2019.[9][10] From 2008 to 2019, the chief executive of the agency was Tatsuya Kondo, a neurosurgeon and graduate of the University of Tokyo.[11]

References

  1. ↑ Kato, K. (2015). "Japan's pharmaceutical regulatory system". Clinical Therapeutics.
  2. ↑ 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]
  3. ↑ Sasinowski, Frank; Valdez, Kristina (2016). "Regulatory systems for drugs and biologics in Japan". Therapeutic Innovation & Regulatory Science.
  4. ↑ 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)
  5. ↑ Shimazawa, Ryo (2018). "Regulatory harmonization and electronic submissions in Japan". Therapeutic Innovation & Regulatory Science.
  6. ↑ 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]
  7. ↑ Kuribayashi, Ryosuke; Matsuhama, Maki; Mikami, Kenichi (2015). "Regulation of Generic Drugs in Japan: The Current Situation and Future Prospects". The AAPS Journal. 17 (5): 1312–1316. doi:10.1208/s12248-015-9777-x.
  8. ↑ Kato, Kazuto (2015). "Japan's Pharmaceutical Regulatory System". Clinical Therapeutics.
  9. ↑ "Yasuhiro Fujiwara, M.D., PHD Chief Executive, Pharmaceuticals and Medical Devices AgencyJapan" (PDF). Retrieved 30 November 2025.
  10. ↑ "New PMDA Head Yasuhiro Fujiwara Sets Out Top Priorities for Japan's Drug Regulator". Pink Sheet. 2019.
  11. ↑ "Unsung Hero: Dr. Tatsuya Kondo". The ACCJ Journal. Retrieved 30 November 2025.

Further reading

Notes

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