One-stop Service before approval involving Risk Evaluation, Document Organization, Register, Clinical Trial, Progress Tracking.
Application Information Requirements of Chemical Drugs
A Summary
1) Name of the drugs.
2) Certified Documents.
3) Objectives and basis for R & D.
4) Summary of main study work.
5) Draft of packaging insert, note to the draft, and latest literature.
6) Design of packaging and labeling.
B Pharmaceutical data
7) Summary of Pharmaceutical Study,
8) Research information and relevant literature of the production process of the drug substance, research information and relevant literature of formula and process of the preparations.
9) Study information and relevant literature for the chemical structure and components determination.
10) Study information and literature for quality specification.
11) Draft of quality specification and notes, and providing reference standard.
12) Test report of drug sample.
13) The source, test report and quality specification of drug substance and excipient.
14) Stability study and relevant literature.
15) Selection basis and quality specification of immediate packing material and container.
C Pharmacology and toxicology study information.
16) Summary of pharmacology and toxicology study.
17) Primary pharmacodynamics study and literature.
18) General Pharmacology study and literature.
19) Acute/single dose toxicity study and literature.
20) Repeated dose toxicity study and literature.
21) Special safety study and literature of hypersensitive (topical, systemic and photo-toxicity), hemolytic and topical irritative (blood vessel, skin, mucous membrane, and muscle) reaction related to topical and systemic use of the drugs.
22) Study and relevant literature on Pharmacodynamics, toxicity and pharmacokinetics change caused by the interactions amongst multiple components in the combination products.
23) Study and literature of mutagenicity test.
24) Study and literature of reproductive toxicity.
25) Study and literature of carcinogenicity test.
26) Study and literature of drug dependence.
27) Study and literature of pre-clinical pharmacokinetics.
D Clinical Study Information
28) Summary of global clinical study information.
29) Clinical study protocol.
30) Investigator’s Brochure.
31) Draft of Informed Consent Form, approval of the Ethics Committee.
32) Clinical study report.
The process of import pharmaceutical registration
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