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Requisite data for IPEL (import pharmaceutical excipient license)

Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |

A  Summary

1) Names of pharmaceutical excipient.

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 Manufacturing Process.

9) Experiment Data and Information and Relevant Literatures on the Chemical Structure Elucidation.

10) Experiment Data and Information on the Research of Drug Quality Specification and analysis procedure and Related Literatures.

11) Experiment Data and Information and Relevant Literatures on pairing with drug.substances.

12) Draft of Quality Specifications and Testing Method and, Relevant Reasons Why Those Decisions being Made.

13) Certificate of Analysis (COA) of continuous 3 batchs 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) Study and Literatures of effect to Pharmacodynamics of drug substances.

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

25) Summary of Clinical Study Information.

26) Investigational Plan and Clinical Study Protocol.
27) Investigator’s Brochure.
28) Sample of Informed Consent Form, Approval of the Ethics Committee.
29) Clinical Study Report.

The more detailed requirements for each document please refer to our Reference Brochure for Application for Imported Pharmaceutical Excipient License.