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Japanese Drug and Device Agency

Licensing activities to be merged within new agency to be established

A new joint regulatory agency for pharmaceuticals and medical devices is to be established in Japan on 1 April 2004 following promulgation of Law No 192 on 20 December 20021. The new financially independent agency, which will operate under the existing Pharmaceuticals and Medical Safety Bureau (PMSB) of the Japanese Ministry of Health, Labour and Welfare (MHLW), will merge the following bodies:

In doing so it will manage not only pre-market approval and licensing of pharmaceuticals and devices including animal tissue products,...

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