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Further Reforms in Approval Process for Clinical Trials

May. 11, 2017

As announced on May 11, 2017, China’s CFDA is backing away from its certification system, currently requiring any applicant for clinical trials to go through a laborious certification process (usually taking 12-18 months), and switch to the “US style” - “no response means approval” mechanism.

Under the new scheme, rather than waiting for a “green light” from the CFDA prior to starting a clinical trial, an applicant will have an automatic approval if the agency hasn’t rejected the applications within 60 working days.