Part of the administrative examination and approva
April 5th, CFDA official website announced the State Food and Drug Administration on the adjustment of some of the administrative examination and approval procedures for the approval of the decision, will be implemented from May 1st.
According to the "decision", are made by the State Food and Drug Administration and Drug Administration approval decision by the State Food and Drug Administration Center for drug evaluation made by the State Food and Drug Administration name:
First, the drug clinical trial approval decision (including domestic and imported);
In two, the approval of the application for approval of drug supplements (including domestic and imported);
Three, the re registration of imported drugs decision.
The decision on the examination and approval of the application for registration of other drugs shall be made by the State Food and Drug Administration in accordance with the present procedures.
The examination and approval decision shall be issued by the person in charge of the center for drug evaluation of the State Food and drug administration. If the applicant refuses to accept the conclusion of the examination and approval, he may bring an administrative reconsideration or bring an administrative lawsuit to the State Food and drug administration.
On the adjustment of the time limit for approval
The time limit for examination and approval in accordance with the provisions of the administrative measures for the administration of drug registration.
Two examination and approval procedures for the re registration of imported drugs
Apply for re registration of imported drugs nuclear file program, nuclear file work according to the original program to carry out nuclear file; after the completion of the work, seized the hospital registration information will be submitted to the General Administration of drug trial centers, do not need to carry out the standard of review, enter the administrative approval procedures, to carry out the standard of review, technical review into the link.
Three approval procedures for supplementary applications that do not require technical reviews
To supplement without the technical review application matters (supplementary original state administration of direct examination and approval or archival filing application), according to the original declaration procedures after receiving the acceptance department will declare the information submitted to administration of drug trial centers, to carry out the work of the administrative examination and approval.
Four on the registration certificate issued time
The relevant approval procedures after the adjustment, the center for administration of drug review approval to send reception center, production, drug approval documents served by the reception center according to the original work program to carry out.
Five procedures for the approval of documents and their attachments
If the applicant considers that the approval documents or the contents of the attachments are incorrect, the applicant may submit a written application for an amendment to the original administrative examination and approval unit of the specific application.