Regulation of biosimilars in Japan

05:19 EDT 23 Sep 2016 | Generics and Biosimilars Initiative

Biosimilar regulations, based on the European Union’s existing processes, were issued by Japan’s regulatory body for the approval of medicines, the Ministry for Health Labour and Welfare (MHLW), in March 2009 [1]. The MHLW’s regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), provides consultations concerning the clinical trials of new drugs and medical devices and handles biotechnology medicines, including biosimilars.

Original Article: Regulation of biosimilars in Japan


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