Abstract
This paper mainly deals with pharmaceutical products which are the responsibility of the Pharmaceuticals and Cosmetics Division of the Pharmaceutical Affairs Bureau in the Ministry of Health and Welfare (MHW) of Japan. These pharmaceutical products include drugs which are produced by utilizing biotechnology. An overview of the evaluation and registration procedures for these biological drug products is given here.
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Yamada, M. The Approval System for Biological Products in Japan. Ther Innov Regul Sci 31, 1385–1393 (1997). https://doi.org/10.1177/009286159703100444
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DOI: https://doi.org/10.1177/009286159703100444