China: Update on IP and regulatory developments

David Shen

The Chinese Food and Drug Administration (CFDA) recently released a number of new guidelines and regulations to implement the directives from the Central Government Opinion released on 8 October 2017 (see our earlier post: Chinese medicinal product approval reform announced). These new guidelines and regulations represent the efforts made by CFDA to promote innovation in the Chinese pharmaceutical and medical device industry.

This report aims to summarise some of the recent important regulatory updates that will affect the pharmaceutical industry, including the new Chinese “Orange Book,” change to the active pharmaceutical ingredient approval, change to clinical trial application approval, conditional approval process for urgently needed drugs, the Chinese “Named Patient Program,” and a medicinal product Marketing Authorisation Holder’s reporting responsibility on adverse events.


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