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Requisite application documents for Drug CFDA(SFDA) Approval

1. As to Drug Substances (viz. Active Pharmaceutical Ingredients (API), Bulk Drugs)

A Summary

1) Drug Names.

2) Certifications.

3) Basis, Objectives and Reasons Referring to the Application and R & D.

4) Summary of Main Studies.

6) Sample of Packaging and Labeling Draft.

B Pharmaceutical Data

7) Summary of Pharmaceutical Research,

8) Experiment Data and Information and Relevant Literatures on the Research of Manufacturing Process for the Drug Substance.

9) Experiment Data and Information and Relevant Literatures on the Chemical Structure Elucidation and Components Determination.

10) Experiment Data and Information on the Research of Drug Quality Specification and analysis procedure and Related Literatures.

11) Draft of Quality Specifications and Testing Method and, Relevant Reasons Why Those Decisions being Made.

12) Certificate of Analysis (COA) of Sample Product.

14) Experiment Data and Information on the Research of Drug Stability and Related Literatures.

15) Reasons for the Selection of the Kind of Direct Packaging Material/ Container, and the Quality Specification & Testing Method for those Material/Container.

C Pharmacology and Toxicology Study Information

(Literatures are acceptable if they are appropriate, so you could provide appropriate literatures to substitute for experiment information alternatively)

16) Summary of Pharmacology and Toxicology Study.

17) Primary Pharmacodynamics Study and Literatures.

18) General Pharmacology Study and Literatures.

19) Acute/Single Dose Toxicity Study and Literatures.

20) Chronic Toxicity Study and Literature.

21) Special Safety Study and Literatures of Hypersensitive (topical, systemic and photo-toxicity), Hemolytic and Topical Irritative (to blood vessel, skin, mucous membrane, and muscle) Reaction.

22) Study and Relevant Literatures on Pharmacodynamics, Toxicity and Pharmacokinetics Changes Caused by the Interactions amongst Multiple Components in the Compound Product.

23) Study and Literatures on Mutagenicity Test.

24) Study and Literatures on Reproductive Toxicity.

25) Study and Literatures on Carcinogenicity Test.

26) Study and Literatures on Drug Dependence.

27) Study and Literature on Pre-clinical Pharmacokinetics.

D Clinical Study Information

28) Summary of Clinical Study Information.

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2. As to Drug Products (viz. Preparations, Formulations and Dosage Products)

A Summary

1) Drug Names.

2) Certifications.

3) Basis, Objectives and Reasons Referring to the Application and R & D.

4) Summary of Main Studies.

5) Draft of Packaging Insert; Explications on the Reason to Make It; and Literatures.

6) Sample of Packaging and Labeling Draft.

B Pharmaceutical Data

7) Summary of Pharmaceutical Research,

8) Experiment Data and Information and Relevant Literatures on the Research of Formula Constitution and Manufacturing Process for the Preparations.

10) Experiment Data and Information on the Research of Drug Quality Specification and analysis procedure and Related Literatures.

11) Draft of Quality Specifications and Testing Method and, Relevant Reasons Why Those Decisions being Made.

12) Certificate of Analysis (COA) of Sample Product.

13) The Sources, VOA and Quality Specifications and Testing Method of Drug substance and Excipients.

14) Experiment Data and Information on the Research of Drug Stability and Related Literatures.

15) Reasons for the Selection of the Kind of Direct Packaging Material/ Container, and the Quality Specification & Testing Method for those Material/Container.

C Pharmacology and Toxicology Study Information

(the literature is acceptable if its available and appropriate, so you could provide appropriate literature to substitute for study alternatively)

16) Summary of Pharmacology and Toxicology Study.

17) Primary Pharmacodynamics Study and Literatures.

18) General Pharmacology Study and Literatures.

19) Acute/Single Dose Toxicity Study and Literatures.

20) Chronic Toxicity Study and Literature.

21) Special Safety Study and Literatures of Hypersensitive (topical, systemic and photo-toxicity), Hemolytic and Topical Irritative (to blood vessel, skin, mucous membrane, and muscle) Reaction.

22) Study and Relevant Literatures on Pharmacodynamics, Toxicity and Pharmacokinetics Changes Caused by the Interactions amongst Multiple Components in the Compound Product.

23) Study and Literatures on Mutagenicity Test.

24) Study and Literatures on Reproductive Toxicity.

25) Study and Literatures on Carcinogenicity Test.

26) Study and Literatures on Drug Dependenc, e.

27) Study and Literature on Pre-clinical Pharmacokinetics.

D Clinical Study Information

(If you want a waiver of clinical trials in China, you¡¯d better provide the following information/data on clinical study conducted in the manufacturing country as detailed as you can, if the reviewers think the information/data and literature you provided are appropriate, the clinical trials may be exempted )

28)Summary of Domestic and International Clinical Study.
29) Investigational Plan and Clinical Study Protocol.
30) Investigator¡¯s Brochure.
31) Sample of Informed Consent Form, Approval of the Ethics Committee.
32) Clinical Study Report.

The more detailed requirements for each document please refer to our Reference Brochure for Application for Imported Drugs License.

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