Declaration materials
Part1: Overview materials
1. Name of the medicines
2. Profiles of proof
3. Purpose and evidence of the proposal
4. Summary and review of main research results
5. Medicine directions, draft instructions and related references
6. Design drafts of the package and logo.
Part2: Pharmaceutical research materials
7.Overview of pharmaceutical research
8.Research and reference materials of API manufacturing process; Research and reference materials of prescriptions and manufacturing process of preparations.
9.Experimental materials and references of confirming medicine chemical structure or components
10.Experimental materials and references of quality research
11.Pharmaceutical standards and draft instructions with standard products or control samples
12.Analytical report of samples
13.The source, quality standard and analytical reports of API and adjuvants
14.Experimental materials and references of medicine stability research
15.Selection criteria and quality standards of packing materials and containers which directly contact the medicine
Part3: Pharmacological and toxicological research materials
16.Overview of pharmacological and toxicological research materials
17.Main pharmacodynamic experimental materials and references
18.General pharmacological experimental materials and references
19.Acute toxicity experimental materials and references
20.Long-term experimental materials and references
21.Allergic (partial, systemic and photosensitive toxicity), hemolytic and partial stimulation (blood vessels, skin, mucosa and muscles, etc.) and other special safety experimental materials and references
22.Experimental materials and references of interactions of multi-components’ properties, toxicity and pharmacokinetics in compound preparation
23.Mutagenic experimental materials and references
24.Reproductive toxicity experimental materials and references
25.Carcinogenic experimental materials and references
26.Dependence experimental materials and references
27.Non-clinical pharmacokinetic experimental materials and references
Part4: Clinical experimental materials
28.Overview of domestic and overseas relating clinical experimental materials
29.Clinical test plan and research scheme
30.Clinical researchers’ manual
31.ICF sample manuscript, Ethics committee’s approval
32.Clinical test reports
PS: Part 2 (Pharmaceutical research materials) is supposed to be sorted according to module 3, CTD. Specific requests of CFDA are consistent with that of FDA. Some details need to be discussed specifically and CFDA may have more requests than FDA does.。