Regulatory Focus™ > News Articles > Japan's PMDA Reorganizes Biologics Offices

Japan's PMDA Reorganizes Biologics Offices

Posted 15 October 2012 | By Ansis Helmanis

Japan's Pharmaceutical and Medical Device Agency (PMDA) has reorganized its Offices of Biologics I and Biologics II, respectively, into new entities known as the Office of Cellular and Tissue-based Products and the Office of Vaccines and Blood Products.

As of 1 October 2012, the Office of Cellular and Tissue-based Products will be responsible for cellular and tissue-based products, CMC of gene therapy products, CMC/quality of biologics, biosimilars, and Cartagena Act related work.  The Office of Vaccines and Blood Products will be responsible for vaccines, blood products, and antitoxins. 

The reorganization was prompted by the government's "Five-year Strategy for Medical Innovation," which includes strengthening PMDA's regulation of cellular and tissue-based products.


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