Changing the Review Process: The View of the Japanese Ministry of Health and Welfare

Abstract

On the basis of the discussion at the Committee for Drug Safety Ensuring Measures, the Japanese Ministry of Health and Welfare (MHW) has amended the Pharmaceutical Affairs Law (PAL) and related laws, and is reforming its review system for new drugs. Under the amendments, good clinical practice (GCP) is mandatory for all clinical trials, Phase 1 protocols are reviewed within 30 days of submission, and advice on all protocols is provided by the Organization for Drug ADR Relief, R&D Promotion and Product Review (the drug organization), if required. Good postmarketing surveillance practice (GPMSP), is mandatory for all postmarketing surveillance as GCP is for clinical trials. Structural reform of the review system will strengthen the MHW’s intervention at the clinical trial stage; strengthen compliance reviews of documents for approval, reexamination, and reevaluation applications; improve the quality of the review process; and bolster the collection of data on adverse drug reactions.

The drug organization conducts compliance reviews on the documents for applications and GCP inspection. Review of applications will be conducted jointly by the Central Pharmaceutical Affairs Council (CPAC) and the Pharmaceuticals and Medical Devices Evaluation Center (the review center), a new research institute under the MHW. The MHW is now executing a policy of transparency regarding the review process, and the reports prepared by the review center and CPAC as well as the GCP inspection report will be made public after drug approval.