The General Office of the China Food and Drug Administration ("CFDA") has recently released the Announcement on Matters Concerning the Evaluation and Approval of Registering Imported Drugs (Draft for Comment) (the "Draft for Comment") for public consultation by March 2, 2018.
According to the Draft for Comment, the CFDA has decided to cancel the procedures for checking archives for the re-registration of imported drugs and provided clarity on the following matters. First, from the issue date of this announcement, after an application filed for re-registering imported drugs is accepted, all materials shall be referred to and evaluated by the Center for Drug Evaluation under the CFDA. Second, applications for re-registering imported drugs that have been accepted, including those registration applications with the opinions on checking archives for imported drug re-registration purposes stating that there is no need to recheck the quality standards, shall be all referred to the Center for Drug Evaluation under the CFDA for evaluation and approval. Third, the Registration Certificate for Imported Drugs and the Registration Certificate for Pharmaceutical Products shall be numbered in a new way. Fourth, other matters not mentioned in the announcement shall still be subject to existing rules.