Application Information Requirements of Chemical Drugs as per new registration category
Chapter I
Application Information Requirements for Category 1, 2, 3, 5.1
I. Required items
(I) Summary
1. Name of the drug
2. Certified Documents
2.1 Certified documents for category 1, 2, 3
2.2 Certified documents for category 5.1
3. Objectives and basis for R&D
4. Self-Asssment Report
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5. Information of Marketing Authorization Holder
喝酒划拳怎么玩6. Information of original drug
7. Draft of packaging inrt, note to the draft, and relevant reference literature
8. Specimen of the designed package and label
(II) Summary of the main Studies
9. Summary of pharmaceutical studies
10. Summary of non-clinical studies
11. Summary of clinical studies
(III) Pharmaceutical studies data/documents
12. (3.2.S) Drug Sunstance (3.2.S is the No. of CTD format)画简笔画
12.1 (3.2.S.1) General information
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12.2（3.2.S.2 ）Manufacture
12.3（3.2.S.3 ）Characterisation
12.4（3.2.S.4）Control of drug substance
12.5（3.2.S.5）Reference standards or materials
12.6（3.2.S.6）Container Closure System
12.7（3.2.S.7）Stability
13. （3.2.P） Drug Product
13.1（3.2.P.1）Description and composition of the drug product
13.2（3.2.P.2）Pharmaceutical development
13.3（3.2.P.3）Manufacture
13.4（3.2.P.4）Control of drug substance and excipients
13.5（3.2.P.5）Control Drug Product
13.6（3.2.P.6）Reference standards or materials
13.7（3.2.P.7）Stability
(IV) Nonclinical studies data/documents
14.Summary of nonclinical studies
15.Main pharmacology tests documents and literatures
16.Safety pharmacology tests documents and literatures
17.Singe-do toxicity tests documents and literatures
18.Repeat-do toxicity tests documents and literatures
19.Genotoxicity tests documents and literatures
万象200420.Reproductive toxicity tests documents and literatures
21.Carcinogenicity tests documents and literatures
22.Dependence tests documents and literatures
23.Special safety tests documents and literatures including but not limited to hypersusceptibility (topic, pantasomatous and photonstitive toxicity), hemocytolysis and topical topical irritation (blood vesl, skin, mucous memberbrance, muscle and etc.)
24.Other safety tests documents and literatures豆腐脑制作方法
25.Nonclinical pharmacokinetics tests documents and literatures
26. Tests documents and literatures on mutual effect between pharmacology, toxicity and pharmacokinetics of the multiple ingredients in compound drug products/formulation (V) Clinical tests documents
27.Summary of clinical tests documents
28.Clinical tests plan and study protocol
29. Data management plan, statistical analysis
30.Investigator’s brochure
31.Draft of informed connt form, approval of the ethics committee, review report of science committee
32.Clinical tests report
33. Electronic file of clinical tests data
34. Report of data management, report of statistical analysis
(III) Pharmaceutical studies data/documents
12. (3.2.S) Drug Substance
12.1 (3.2.S.1) General Information农业银行笔试题
3.2.S.1.1 Name of the drug
Plea provide Chine and English generic names, chemical names, CAS numbers and other names of drug substance (including tho in foreign pharmacopoeia).
3.2.S.1.2 Structure
Plea provide the structural formula, molecular formula, and molecular weight of Drug substance. If there are three-dimensional structures and polymorphs, it should be specified.
3.2.S.1.3 Physicochemical properties
Plea provide the physical and chemical properties of the drug substance (generally derived from pharmacopoeia and Merck index, etc.), including the following information: character (such as appearance, color, physical state); melting point or boiling point; specific rotation, solubility, solution pH, Partition coefficient, dissociation constant, physical form (such as polymorph, solvate, or hydrate) that will be ud for preparation production, particle size, etc..
12.2(3.2.S.2) Manufacture
3.2.S.2.1 Manufacturer绿拼音怎么打
Plea provide the manufacturer's name (full name), address, telephone number, fax number, and the address of the production site (specifically to the plant/shop, production line), telephone, fax, etc.
3.2.S.2.2 Manufacturing process and control
(1) Flow chart: A flow chart is provided according to the process steps, indicating the process parameters and the solvent ud. For chemically synthesized drug substance, it should also provide its chemical reaction formula, which should include the starting materials, intermediates, molecule formula/molecule weight/structure of the reagents.
(2) Description of the manufacture process: The process operation is described by the process flow, reprented by the registered batch. The amounts of each reaction material and the yield
range of each step are listed, and the key production steps, key process parameters and quality control indicators of the intermediates are clarified.
(3) Equipments: Plea provide the information of the main and special equipments (such as type, technical parameters, common batch size range, manufacturer, the reaction steps ud).
(4) Indicate the batch size range of commercial batches.
The detailed degree of production process description should enable the technicians of this specialty to completely repeat the production process according to the declared production process and produce products that meet the standards.
3.2.S.2.3 Control of materials
According to the process in the process flow chart, all the materials ud in the production (such as starting materials, reagents, solvents, catalysts, etc.) are listed in the form of a table, and the steps ud are explained. An example is as follows:
Table 1(Note: rial number, the same below): material control information
Plea provide quality control information for the above materials, specify reference standards, or provide internal control standards (including items, testing methods and limits), and provide necessary methodological verification data.
For the key starting materials, the preparation process data should be provided according to the relevant technical guidelines and technical requirements.
3.2.S.2.4 Control of critical step & intermediate
List all key steps (including final product refining and purification process steps) and control range of process parameters.
List the quality control standards for isolated intermediates, including items, methods and limits, and provide necessary methodological verification data.
