Medical network - April 6, April 5, the CFDA's website administration of the state food and drug supervision and administration on adjusting part of the decision of the administrative examination and approval procedures for examination and approval matters in the "drug, will take effect on May 1. 

 

According to the "decision", by the state food and drug administration under the administration of drug administrative examination and approval decision, adjustment of drug approval by state food and drug supervision and management of the administration center in the name of the state food and drug supervision and management of administration to make: 

 

A clinical trials, drug examination and approval decision (including domestic and imported); 

 

Second, the drug supplementary application for examination and approval decision (including domestic and imported); 

 

Third, imported drugs registration approval decision again. 

 

Other for drug registration, examination and approval decision according to the program, managed by the state food and drug administration. 

 

After adjusting the examination and approval decision by the state food and drug administration bureau of drug approval, head of the center. If the applicant is not satisfied with the conclusion of examination and approval, can to the administration of state food and drug supervision and administration of administrative reconsideration or institute an administrative lawsuit in accordance with the law. 

 

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About the time limit for examination and approval of the adjusted 

 

After the adjustment time limit for examination and approval in accordance with the "measures for the administration of drug registration regulation of the time limit of administrative examination and approval is carried out. 

 

The examination and approval of imported drugs registration nuclear file again 

 

Application for imported drugs registration again nuclear program, the nuclear file works carried out according to the original procedure; Nuclear file, after the completion of work in the hospital for further registration information submitted to the administration of human medicinal center, don't need to carry out the standard of review, enter the link of administrative examination and approval, the need for review of the standard, into the technical evaluation. 

 

Three about does not need additional apply for examination and approval procedures for technical evaluation 

 

For matters without technical review of the supplement (the former state administration examination and approval or archival filing supplementary application matters directly), according to the original filing acceptance procedures after acceptance, acceptance department will declare data submitted to the administration of human medicinal center, to carry out the administrative examination and approval work. 

 

Four on the registration certificate issued by the time 

 

Relevant approval procedures, administration of drug approval documents review center will send center, drug approval documents making, carried out by accepting center according to the original work procedure. 

 

Five errata program about the approval documents and accessories 

 

Applicants think approval certificate or the attachment content is wrong, can apply to the specific items of the original unit put forward written application for correction of administrative examination and approval, is responsible for the verification by the original examining and approving units to handle related matters.