Recently, the China Food and Drug Administration ("CFDA") has issued the Announcement on Relevant Matters concerning the Drug Re-registration (Draft for Comment) (the "Draft for Comment") for public comments before April 13, 2017.
The Draft for Comment aims to implement relevant requirements stipulated in the Opinions of the State Council on the Reform of Evaluation and Approval System for Drugs and Medical Devices, providing that a type of drug will not be re-registered from the promulgation date of this Announcement, where products in different specifications under such type of drug have not been launched in the market or been imported within the validity indicated on the approval certificate for such drug and, as a result, it is not possible to perform the duty of inspecting the quality, curative effects and adverse reactions of the drug constantly; and the approval number (the Imported Drugs Registration Certificate and the Pharmaceutical Products Registration Certificate) will be deregistered upon its expiration.