China - Decisions on Adjustment of Registration of Imported Drugs

China Food and Drug Administrationtake decision on adjusts the matters of the registration of imported drugs included in the Provisions for Drug Registration. According to Opinions Concerning the Reform of the Review and Approval System for Drugs and Medical Devices issued by the State Council (Guo Fa Notice [2015] No.44), the approved foreign new drugs which have not been put into market are encouraged to do synchronous clinical trials both in China and abroad. This decision withdraws the requirement that the clinical trial drug should have been registered or have entered Phase II or III of clinical trial abroad. After the completion of Multi-regional Clinical Trial, New Drug Application could be submitted directly.

Products covered : Chemical Drugs, Biological products, Medicaments

Proposed date of adoption : To be determined

Proposed date of entry into force : To be determined

Final date for comments : 60 days after circulation by the WTO Secretariat

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.