China formally approves marketing authorization pilot and pharma contract manufacturing

20 June 2016

China’s State Council has formally authorized a pilot for a new drug marketing authorization holder (MAH) system for 10 of its 23 provinces.

Pharmaceutical research institutions and individual researchers in these provinces can now submit applications for clinical trials or marketing authorization.

Applicants which successfully gain authorization and approval documents can become MAHs and take legal responsibility for clinical trials, production and marketing, something which was previously not allowed.

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