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, the Spanish Agency of Medicines and Medical Devices in Spain or the Food and Drug Administration in the Philippines.[2]
| 独立行政法人医薬品医療機器総合機構 | |
 | |
| Agency overview | |
|---|---|
| Formed | April 1, 2004 |
| Employees | 873 |
| Website | www |
The PhMDA has been eCTD compliant at least since December 2017.[3]
Tasks
editAmong other things, the agency is tasked with the following:
- Drug and medical device testing:
- 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:
- 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:
- 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
editThe 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
edit- ^ "Japan Medical Device Registration". Qualtech.
- ^ 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.
- ^ "ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide in Japan v1.2.0" (PDF). PhMDA. December 2017.