CFDA Proposes Draft Lowering Barriers for Foreign Drug Manufacturers

In March 2017, the China Food and Drug Administration (CFDA) has released draft rules allowing Multinational Companies to include Chinese patients in the earliest possible stages of drug multi-regional clinical trials (MRCTs). These policies are meant to significantly reduce foreign drug registration timelines. The changes affect the following areas:

1) For imported chemical drugs and therapeutic biologics, drug manufacturers undergoing MRCTs no longer need to reach phase II or III in other markets before submitting applications to begin trials in China.

2) Once an MRCT is complete, a drug listing application can be submitted immediately. Approval in the home market before filing an NDA in China will no longer be needed.

3) If certain requirements are met, data gathered during international clinical trials can be used for approval in China, as long as the trials include China.

4) The CFDA has been actively working to improve drug approval process. Recent changes include reducing the drug application backlog from 22,000 to 8,000 and opening up an expedited review process for drugs with “significant therapeutic values”.

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