On 12 May 2017, the Chinese Food and Drug Administration (the “CFDA”) issued several draft policies aimed at overhauling of the current regulations governing the Chinese pharma and medical device sector (the “Draft Policies”). Amongst the Draft Policies, those outlined in Circular No.55 would, if implemented, establish a more robust patent linkage system, a more extensive data exclusivity regime and create a Chinese version of the US Orange Book. In this article, we highlight some of the proposed changes.
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