As to New Pharmaceutical Excipient china CFDA registration, there are 29 application documents must be collected and submitted to the CFDA. Documents must be in both Chinese and original language or English:
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) Research Data and Literature of Production Process.
9) Experiment Data and Related Literatures that Confirm Its Chemical Structure or Components.
10) Experiment Data and Related Literatures on Quality Research.
11) Experiment Data and Related Literatures on Compatibility on Drugs.
12) Draft of Standards and Instructions for the Draft with Standard Product and Test Product Provided.
13) Test Report for Three Continuous Batches of Samples.
14) Experiment Data and Related Literatures on Stability Research.
15) Reasons for the Selection of the Kind of Direct Packaging Material/ Container, and the Quality Specification & Testing Method for those Materials/Containers.
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 Pharmacodynamic 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 Literatures on Mutagenicity Test.
23) Study and Literatures on Reproductive Toxicity.
24) Study and Literatures on Carcinogenicity Test.
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.
As to Generic Pharmaceutical Excipient china CFDA registration , the application documents No.1- 15 above must be collected and submitted to the CFDA. Documents must be in both Chinese and original language or English.
The more detailed requirements for each document please refer to our Reference Brochure for Application for Import Pharmaceutical Excipient License.
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