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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