Pharmaceuticals and Medical Devices Agency
独立行政法人医薬品医療機器総合機構
Pharmaceuticals and Medical Devices Agency.svg
Agency overview
FormedApril 1, 2004
Employees873
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, Dokuritsu-gyōsei hōjin iyakuhin-iryō-kiki-sōgō-kikō) (PhMDA) is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices[1] in Japan. It is similar in function to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom or the Food and Drug Administration in the Philippines.[2]

The PhMDA has been eCTD compliant at least since December 2017.[3]

Tasks

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

Leadership

The chief executive of the agency is Yasuhiro Fujiwara, former head of the National Cancer Center Japan. From 2008 to 2018, the chief executive of the agency was Tatsuya Kondo, a neurosurgeon and graduate of the University of Tokyo.

References

  1. ^ "Japan Medical Device Registration". Qualtech.
  2. ^ Nagasaka, Satoru. "An Overview of Pharmaceutical and Medical Device Regulation in Japan" (PDF). Morgan, Lewis & Bockius LLP. Archived from the original (PDF) on 11 February 2014. Retrieved 30 September 2012.
  3. ^ "ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide in Japan v1.2.0" (PDF). PhMDA. December 2017.