Regulatory Aspects of Biotechnology in Japan

Abstract

Pharmaceutical products are subject to the same review and approval process where­ by the application (NDA) are submitted to the Minister of Health and Welfare. Special efforts are made to assure the quality, efficacy, and safety of drugs. The standard processing time is 18 months for new drugs, and a detailed description of this process if provided. The Ministry of Health and Welfare is establishing guidelines for the development biotechnology derived drugs and their review. The main points under consideration include: complete documentation for quality data-preclinical and clinical-even if the same ingredient from a natural product has been approved by the MHW; flexibility by MHW to avoid excessive requirements which would discourage the development of biotechnology products; harmonization with biotechnology guidelines by World Health Organization, European Economic Community and the Food and Drug Administration is being encouraged; and with the expected rapid growth in the biotechnology field, the MHW is committed to keep abreast of the changes within this technology. Two of the Pharmaceutical Affairs Bureau notifications have been issued con­ cerning data requirements for biotechnology products. The two notifications relate to: the recombinant DNA technology in which prokaryotes, especially E. coli, is used as the host cell and to cell culture technology derived drugs.