Abstract
1. Reform is under way in all stages of the drug approval process in Japan. Following a 2-year review, the Ministry of Health and Welfare (MHW) has amended the Pharmaceutical Affairs Law and related laws. 2. The reforms will strengthen the MHW’s role in protocol review, improve the quality of the review process and increase the collection of data on drug reactions. Restructuring within the MHW takes effect in 1997 and staff will double over the next 3 years. 3. Under the amendments, good clinical practice (GCP) is mandatory for all clinical trials. Phase I protocols will be reviewed within 30 days of submission and advice on all protocols can be provided by the Drug Organization, if required. 4. The Drug Organization will check the standard of licensing approval applications and of Re-examination and Re-evaluation Applications. Review of New Drug Applications will be conducted jointly by the Central Pharmaceutical Affairs Council and the Pharmaceuticals and Medical Devices Evaluation Center, a new research institute under the MHW. 5. Finally, the MHW is now executing a policy of transparency regarding the review process, in line with the Japanese government’s move towards freedom of information.
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