China to create new drug regulator as part of government restructuring

China's government unveiled plans under which the China Food and Drug Administration (CFDA) will be incorporated into a newly created state market regulatory administration. The new body will be responsible for market supervision and management, market entity registration and market order maintenance. The government added that due to the specificity of drug supervision, it will form a state drug administration, which will be affiliated to the state market regulatory administration.

State Councilor Wang Yong explained that the proposal aims to resolve existing problems including unclear responsibilities, cross-regulation and a lack of supervision. The move is part of a broader reform of government departments that will see the creation of seven new ministries.  

The overhaul comes after China's State Council announced last year new rules designed to speed the approval of drugs, with data from clinical studies conducted outside the country able to be used to support marketing applications for medicines.

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