Multinational Pharmas: Expect Key Policy Shifts In China
December 3, 2013, 8:04 PM EST
Law360, New York (December 3, 2013, 8:04 PM EST) -- The China Food and Drug Administration ("CFDA") recently announced the Draft Amendment of the Measures on the Administration of Drug Registration (also known as the Drug Registration Rules, "DRR" or DRR Draft Amendment), which is expected to significantly affect the pharmaceutical industry. The CFDA is soliciting public comments on the DRR Draft Amendment through Dec. 13, 2013.
Since Oct. 1, 2007, the DRR has set forth a regulatory framework for issuance of marketing authorizations to locally manufactured and imported drugs. The CFDA aspires to create a more...