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, RD 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 con...
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