After receiving comments on the draft of the Decision of the State Administration of Food and Drug Administration on Adjusting the Relevant Issues Concerning the Registration and Administration of Imported Drugs (the “Decision”) in March 2017, the China Food and Drug Administration (“CFDA”) published the finalised version of the Decision on 10 October 2017. The Decision which takes effect upon publication is generally in line with the previous draft.
The key points are summarised below:
- Phase I of multi-regional clinical trials (“MRCT”) of imported drugs, excluding vaccines, can be conducted in China. Such imported drugs no longer need to be registered overseas or have entered into either Phase II or Phase III of clinical trials abroad beforehand.
- Upon completion of the MRCT in China, the marketing application of the imported drug can be submitted immediately. The application should comply with the Administration Measures for Drug Registration and other applicable guidelines.
- Imported drugs applying for clinical trials, and imported new chemical drugs and/or innovative therapeutic biological products applying for marketing registration, are no longer required to be registered abroad beforehand.
- Imported drugs which clinical trial applications have been accepted by the authority before the publication of the Decision, and have also applied for the exemption of clinical trials by using the data obtained from MRCT, may be approved for marketing directly, provided that the requirements of the Administration Measures for Drug Registration and other applicable guidelines have been satisfied.
The Decision will significantly shorten the registration period for imported drugs, providing greater business opportunities for multi-national pharmaceutical companies. Chinese patients will be able to access new drugs in shorter time.