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	ANNOUNCEMENT OF THE STATE FOOD AND DRUG ADMINISTRATION ON THE IMPLEMENTATION OF ADMINISTRATIVE LICENSING FOR CERTAIN ITEMS

	(SFDA Regulations No. 504 [2004], October 14, 2004)


SUBJECT : ADMINISTRATIVE LICENSING
ISSUING DEPARTMENT : STATE FOOD AND DRUG ADMINISTRATION
ISSUE DATE : 10/14/2004
IMPLEMENT DATE : 10/14/2004
LENGTH : 932 words
TEXT :

Administrative licensing items to be implemented by the State Food and Drug Administration are hereby announced as follows for the purpose of implementing the Administrative Licensing Law of the People's Republic of China:

I. In accordance with the Drug Administration Law of the People's Republic of China, Food Hygiene Law of the People's Republic of China, and the Bidding Law of the People's Republic of China, the following 18 administrative licensing items shall be implemented:

1. Issuance Of New Drug Certificates;
2. Approval Of Drug Clinical Trials;
3. Issuance Of Import Drug (Including Import Crude Drugs) Registration Certificates;
4. Approval Of Drug Immediate Packaging Materials And Containers;
5. Issuance Of Import Drug Customs Clearance Forms;
6. Approval Of Entrusted Drug Manufacturing;
7. Approval Of Professional Journals Carrying Prescription Drug Advertisements;
8. Approval Of Health Food;
9. Approval Of Medical Institutions Dispensing And Adjusting Pharmaceutical Preparations;
10. Certification Of Good Supply Practice (GSP);
11. Issuance Of Drug Manufacturing Certificates And Drug Supply Certificates;
12. Issuance Of Pharmaceutical Preparation Certificates For Medical Institutions;
13. Approval Of Production Of New Drugs Or Drugs Admitted By National Drug Standards;
14. Certification Of Good Manufacturing Practice (GMP);
15. Confirmation Of The Qualification Of Drug Clinical Trial Institutions;
16. Confirmation Of The Qualification Of Drug Purchase Tender Bidding Agencies;
17. Examination Of Drug Advertisements; And
18. Confirmation Of The Qualification Of Health Food Testing Institutions.

II. In accordance with the Implementing Regulation for the Drug Administration Law of the People's Republic of China, Regulation for the Supervision and Administration of Medical Devices, Anti-Doping Regulation, Measures for the Control of Narcotic Drugs, Measures for the Control of Psychotropic Drugs, Measures for the Control of Medicinal Toxic Drugs, Measures for the Control of Radioactive Pharmaceuticals, Regulation on the Protection of Traditional Chinese Medicinal Products, Regulation on the Administrative Protection of Pharmaceuticals, and the Measures of the People's Republic of China for the Administration of Internet Information Services, the following 37 administrative licensing items shall be implemented:

1. Confirmation Of The Qualification Of Medical Device Clinical Trial Institutions;
2. Approval Of New Drug Interim Standards To Become Formal Standards;
3. Registration Of (Hong Kong, Macao And Taiwan) Pharmaceutical Products;
4. Examination And Verification Of Supplementary Applications With Regard To Drugs;
5. Testing Or Examination And Verification Of Biological Products, As Provided For By The State, In The Stage Of Pre-Sales Or Importation;
6. Re-Registration Of Drugs (Including Imported Drugs And Pharmaceutical Products From Hong Kong, Macao And Taiwan);
7. Registration Of Medical Devices Imported For The First Time;
8. Issuance Of The Licenses For New Medical Devices;
9. Recognition Of The Qualification Of Medical Device Testing Institutions;
10. Compulsory Safety Certification Of Some Of Medical Devices Of Class III;
11. Approval Of The Development And Study Of Narcotics;
12. Approval Of Plans For Planting, Producing And Purchasing Narcotics (Including Medicinal Plants And Compound Preparations);
13. Approval Of Narcotics (Including Psychotropic Drugs Of Category I) Distributing Enterprise;
14. Approval And Record Keeping Of The Development Of Radioactive Drugs;
15. Issuance Of Licenses For Enterprises To Produce And Distribute Radioactive Drugs;
16. Approval Of Enterprises Distributing Raw Materials For Psychotropic Drugs;
17. Approval Of Designated Enterprises For The Manufacturing Of Narcotics And Psychotropic Drugs;
18. Approval Of The Imports And Exports Of Narcotics And Psychotropic Drugs;
19. Registration Of China-Made Medical Devices;
20. Approval Of Clinical Testing (Verification) Of Medical Devices Of Class II And III;
21. Issuance Of Licenses For Enterprises To Manufacture And Distribute Medical Devices Of Class II And III;
22. Issuance Of Certificates For The Purchase And Use Of Narcotics And Of Psychotropic Drugs Of Category I;
23. Issuance Of Licenses For The Use Of Radioactive Drugs;
24. Approval Of Enterprises Distributing Psychotropic Drugs Of Category II;
25. Approval Of Enterprises Distributing Medicinal Poppy Shells;
26. Examination And Verification Of Plans For Purchasing Medicinal Poppy Shells;
27. Approval Of Enterprises Purchasing And Distributing Medicinal Toxic Drugs;
28. Approval Of Agencies Issuing Special Purchasing Cards For Narcotics Used By Cancer Patients;
29. Issuance Of Certificates Of A Protected Traditional Chinese Medicinal Product;
30. Examination Of Medical Device Advertisements;
31. Examination And Verification Of Internet Drug And Medical Device Information Services;
32. Record Keeping Of Entrustments Of The Manufacturing Of Anabolic Agents And Peptide Hormones To A Party Outside The Country;
33. Approval Of Licenses For The Export Of Anabolic Agents And Peptide Hormones;
34. Approval Of Wholesalers Of Anabolic Agents And Peptide Hormones;
35. Approval Of Licenses For The Import Of Anabolic Agents And Peptide Hormones;
36. Administrative Protection Of Pharmaceuticals; And
37. Approval Of The Purchases Of Toxic Drugs Used For Scientific Research And Teaching.

III. In accordance with the Decision of the State Council on Adopting the Form of Administrative Licensing to Matters that Need to Remain Subject to Administrative Examination and Approval (Decree No. 412 of the State Council), the following 12 administrative licensing items shall be implemented:

1. Approval Of The Development Of Psychotropic Drugs;
2. Approval Of Plans For The Production Of Ephedrine Products And Simple Recipe Preparations;
3. Issuance Of Certificates For The Purchase And Use Of Ephedrine Products And Simple Recipe Preparations;
4. Approval Of Manufacturing And Distribution Of Ephedrine;
5. Issuance Of Certificates For The Purchase And Use Of Ephedrine For Export;
6. Issuance Of Certificates For The Purchase And Use Of Caffeine And Ketamine As Pharmaceutical Raw Materials;
7. Certification Of Good Agricultural Practice (GAP) For Chinese Crude Drugs;
8. Certification Of Good Laboratory Practice (GLP);
9. Approval Of Internet Drug Trading Service Providers
10. Registration Of Licensed Pharmacists;
11. Registration Of Pharmaceutical Adjuvant; And
12. Examination Of Health Food Advertisements.