| 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 |
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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]
The PhMDA has been eCTD compliant at least since December 2017.[3]
- ^ "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.