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Published on: July 1, 2014
[Impact of the last 15 years: from PMDEC to PMDA --looking back at the first stage of the PMDEC]
Kazushige Morimoto1, Yasuhiro Fujiwara, Akira Kawahara
1Pharmaceuticals and Medical Devices Agency (PMDA), Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013.
Abstract:
The Ministry of Health and Welfare (MHW) (renamed the Ministry of Health, Labour and Welfare [MHLW] in Jan. 2001) amended the Pharmaceutical Affairs Law, resulting in a fundamental reform of the review system for New Drug Applications, based on the 1996 report of the ad-hoc Committee for Drug Safety Ensuring Measures. One of the most important changes in the review system was the establishment of the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) on July 1, 1997 followed by the Pharmaceuticals and Medical Devices Agency (PMDA) in 2004. In five years, the drug approval system in Japan underwent a series of significant reforms, such as adopting new GCP based on the ICH/E6 (R1), changes relating to ethnic factors in the acceptability of foreign clinical data (ICH/E5 (R1)), and the establishment of a Common Technical Document (CTD) (ICH/M4). The addition of the PMDEC has greatly improved the speed of review for new drugs, especially oncology drugs and orphan drugs. We discuss the philosophy of PMDA in relation to the concept of regulatory science.
Insights
Japan
Area of Science:
- Regulatory Science
- Pharmaceutical Affairs Law
- Drug Approval System
Context:
- The Ministry of Health and Welfare (MHW) reformed Japan's drug review system in 1997.
- Key changes included establishing the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) and later the Pharmaceuticals and Medical Devices Agency (PMDA).
- Reforms aligned with international standards like ICH guidelines (ICH/E6, ICH/E5, ICH/M4).
Purpose:
- To outline the significant reforms in Japan's drug approval system.
- To highlight the establishment and role of PMDEC and PMDA.
- To discuss the impact of these reforms on drug review efficiency.
Summary:
- Japan's drug approval system underwent major reforms, including the establishment of PMDEC/PMDA.
- New Good Clinical Practice (GCP) and the Common Technical Document (CTD) were adopted.
- The reforms improved the review speed for new oncology and orphan drugs.
Impact:
- Accelerated review timelines for new oncology and orphan drugs.
- Enhanced the efficiency and international harmonization of Japan's drug regulatory system.
- Strengthened the foundation for regulatory science in pharmaceutical evaluation.
