Measures for the administration of the registration of imported drugs and the required time 1. To apply for the registration of imported drugs, you should fill in the Application Form for Drug Registration, submit relevant materials and samples, and provide relevant supporting documents (the supporting documents should be notarized at the embassy of the importing country) and apply to the State Food and Drug Administration of the United States. 2. The US Food and Drug Administration needs 30 days to formally review the application materials. Meet the requirements, issued a "notice of acceptance of drug registration application", and notify the China Institute for the Control of Pharmaceutical and Biological Products to organize the registration inspection of three batches of samples. 3 China Institute for the Control of Pharmaceutical and Biological Products shall organize registration inspection within 5 days after receiving the materials and samples. 4. The drug inspection institute undertaking the registration inspection of imported drugs shall complete the registration inspection within 60 days after receiving the materials, samples and related reference materials, and submit the drug registration inspection report to China Institute for the Control of Pharmaceutical and Biological Products. Sample inspection and drug standard review of special drugs and vaccine products shall be completed within 90 days. 5. China Institute for the Control of Pharmaceutical and Biological Products shall, after receiving the drug registration inspection report and the reviewed imported drug standards, organize experts to conduct technical review within 20 days, and if necessary, conduct review according to the review opinions. 6. The Drug Evaluation Center of the US Food and Drug Administration shall organize technicians such as pharmacy and medicine to evaluate the application materials within 120 days. Need supplementary materials, supplementary materials notice issued by the evaluation center, and according to the contents of the notice, one-time supplementary materials within 4 months. It takes 40 days for the drug evaluation center to review the supplementary information. 7. The State Food and Drug Administration of the United States shall make an examination and approval decision within 20 days; If a decision cannot be made within 20 days, it may be extended by 10 days with the approval of the leader of the competent authority, and the applicant shall be informed of the reasons for extending the time limit. 8. The State Food and Drug Administration of the United States shall issue and serve relevant administrative license certificates within 10 days from the date of making the decision on drug registration and approval. 9. After obtaining clinical approval, the applicant shall submit the clinical plan and other materials to the State Food and Drug Administration for the record, and then conduct clinical trials for 6-8 months. 10. Submit the clinical report to the US Food and Drug Administration. The Drug Evaluation Center of the State Food and Drug Administration of the United States should organize technicians such as pharmacy and medicine to comprehensively evaluate the submitted clinical trials and other materials within 120 days. If supplementary information is needed, the assessment center will issue a supplementary information notice, and according to the contents of the notice, it is necessary to complete the supplementary information at one time within 4 months. It takes 40 days for the drug evaluation center to review the supplementary information. 1 1. The State Food and Drug Administration will make an approval decision within 20 days based on the comprehensive opinions. If it meets the requirements, it shall be issued with a Registration Certificate for Imported Drugs. To sum up all the procedures, the processing time of * * * is 23-38 months.