Japanese Perspectives on the Reproductive and Developmental Toxicity Evaluation of Pharmaceuticals

Abstract

The current Japanese guidelines for reproductive and developmental toxicity studies of drugs stress the need for examination of the effects of drugs on the behavior and fertility of the offspring. In 1986, the Ministry of Health and Welfare initiated a review of all current toxicity test guidelines, one of the objectives of the review being to increase the international harmonization of such guidelines. The final report of the Reproduction Study Subgroup was officially released on September 11, 1989. A summary of the conclusions of the study subgroup follows: To attain international conformity of guidelines requires scientific discussion among international organizations, but an early solution will be difficult. A more practical way is to accept studies performed in conformity with other guidelines if the applicant submits a document demonstrating that the same degree of safety for human reproduction and development required by the Japanese guidelines can be judged from the characteristics and clinical indications of the drug., Positive discussion is also necessary with other countries to agree on conditions under which studies performed according to the Japanese guidelines will be acceptable to such countries. In addition, the current status of behavioral teratology tests in Japan surveyed by the Behavioral Teratology Meeting, Japanese Teratology Society is presented.