The China Food and Drug Administration (“CFDA”) issued 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 “Draft”) on 17 March 2017. The Draft will be open for public comments until 20 April 2017.
Four significant changes will be implemented to the multi-regional clinical trials (“MRCT”) regime of drugs that are imported into China:
MCRT of imported drugs (excluding vaccines) can be conducted in China even though the drugs have not been registered overseas or have not entered into either Phase II or Phase III clinical trials. This requirement is currently strictly enforced;
the ‘drug marketing registration’ application can be submitted immediately upon completion of the MRCT in China;
new chemical drugs that are imported as well as new therapeutic biologics are no longer required to be registered abroad; and
a ‘qualified import drug registration’ application supported by clinical data obtained through MRCTs can be approved without local clinical trials.
The Draft aims to encourage overseas drug manufacturers to seek the relevant approvals to carry out clinical trials simultaneously in both China and abroad. This will result in Chinese patients gaining access to new overseas drugs as soon as possible. The Draft will significantly shorten the registration period for imported drugs resulting in greater convenience for multi-national pharmaceutical companies.