Content of licensing: Verification and issuance of registration certificates for imported TCM and natural medicine (incl. from Hong Kong, Macao and Taiwan), their classification follows the Annex I of the “Provisions for Drug Registration”, namely:
Registration Category 1: An active ingredient obtained from plant, animal or mineral materials and its preparations that have not been marketed in China.
Registration Category 2: A newly-discovered Chinese crude drug and its preparations.
Registration Category 3: A new substitute for Chinese crude drug.
Registration Category 4: A new part for medicinal use from currently-used Chinese crude drugs and their preparations.
Registration Category 5: Active fraction(s) extracted from plant, animal or mineral materials and its preparations that have not been marketed in China.
Registration Category 6: A combination preparation of TCM or natural medicinal product, which has not been marketed in China.
Registration Category 7: A preparation with changed administration route of a marketed TCM or natural medicinal product.
Registration Category 8: A preparation with changed dosage form of a marketed TCM or natural medicinal product.
Registration Category 9: Generic TCMs or natural medicinal products
List of application dossiers :
"Application Form for the Registration of Imported Drugs”
(I) General information:
1 Drug name.
2 Proof documents.
3 Project rationale and basis.
4 Summary and evaluation of major findings.
5 Package inserts sample, drafting instructions and the latest references.
6 Packaging and label design samples.
(II) Pharmaceutical research information:
7 Overview of pharmaceutical research data.
8. Sources and identification basis for Chinese crude drugs.
9. Ecological environment, growth characteristics, morphological description, planting or cultivation (culture) technology, producing and processing methods for medicinal herbs.
10. Standard draft and the drafting instructions for Chinese crude drugs and provide pharmaceutical reference materials and relevant information.
11. Provide plant and mineral specimens; plant specimens should include flowers, fruits and seeds etc.
12. Research data, verification data and literature for production process, and the source and quality standards of excipients.
13. Testing data and literature studies of chemical ingredients.
14. Testing data and literature data for quality research.
15. Standard draft and drafting instructions for drugs, and provide reference material of drugs and related information.
16. The sample inspection report.
17. Testing data and literature for drug stability studies.
18. Rationale for selection and specifications of immediate packaging material and container.
(III) Pharmacology and toxicology research data:
19. Review of pharmacology and toxicology research data.
20. Main pharmacodynamic testing data and literature.
21. Testing data and literature in general pharmacology studies.
22. Acute toxicity testing data and literature.
23. Long-term toxicity testing data and literature.
24. Special safety testing data and literature of allergy (topical, systemic and light-sensitive toxicity), hemolysis and local (blood vessels, skin, mucous membranes, muscle, etc.) irritation, dependency studies, etc., which are mainly related to local and systemic administration of drugs.
25. Genotoxicity testing data and literature.
26. Reproductive toxicity testing data and literature.
27. Carcinogenicity testing data and literature.
28. Animal pharmacokinetic studies and literature.
(IV) Clinical trials data:
29. Overview of clinical trial data.
30. Clinical trial plans and protocols.
31. Clinical investigator's brochures.
32. A draft of Informed Consent, Ethics Committee’s approval letters.
33. Clinical trial reports.
Specific requirements for the above application dossiers are detailed in Annex I of the “Provisions for Drug Registration”.
