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 |
| Employees | 873 |
| Website | www |
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] 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 at least since July 2017.[3]
- ^ 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.
- ^ 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.