进口药用辅料注册资料列表-英文版-带详细说明

CFDA Statement No.61 Application Information Requirements of Excipients which issued in 2005, the following items should be submitted.

(I) Summary

1. Name of the excipient.

Include the official name of the excipient, chemical name, English name and Chinese Phonetics name. The Nomenclature basis of the excipient.

2. Certified Documents.

(1) Certified Documents, notarized document for the free sale certificate (FSC) issued from the competent authorities of the local country or region where the manufacturer is located, and the GMP Certificate of the manufacturer, and the Chinese translation.

(2) When the registration of a foreign excipient manufacturer is conducted by manufacturer’s office in China, copies of Registration Certificate for Resident Office of Foreign Enterprise should be provided.

(3) When a foreign excipient manufacturer authorizes domestic agent to conduct the registration, copies of the authorization document, notarized document and the Chinese translation, as well as the Business License of the domestic agent should be provided.

(4) Documents and explanations to evidence the patent status and ownership of the excipient, the formula of the excipient, the production technology and process of the excipient, as well as letters of guarantee stating that the excipient will not infringe upon the patent rights of others.

(5) Notes: ① Certified Documents, notarized document for the FSC and GMP Certificate of the manufacturer should comply with the recommended format by World Health Organization (WHO). The document in other format must be legalized by the Chinese embassy in the original country.

② In the event that the excipients not yet approved to sale in the manufacturing country or region, the Certified Documents from the other country where the products being marketed and documents of DMF could be provided. And the notarized document and the Chinese translation should also be provided. All the documents should be recognized by CFDA. But the certified documents of the GMP for the excipients should be issued by the competent authorities of the local country or region where the manufacturer is located.

③ For application of imported pharmaceutical vacant capsules, gelatin for capsules, pharmaceutical grade gelatin which all are bovine original, the related documents and certificates of the source and category of the raw materials of preparing gelatin which is the main raw material for preparing capsules should be provided. The certificates which issued by the government for demonstrating the raw materials of preparing gelatin were not come from the BSE Country.

3. Objectives and basis for R & D.

Include R&D, market status, related literatures, manufacture, summary about the excipient application in formulations.

4. Summary of main study work.

Include summary for the main research results which had been done by the applicant, overall evaluation of the excipient on safety, effectiveness, quality controllability and etc.

5. Draft of packaging insert, note to the draft, and latest literature

Include instruction for usage of the excipient, includes name of the excipient, chemical structure or molecular formula, usage, cautions, package (strength, content), shelf life, the “Pharmaceutical Excipient” should be labeled.

6. Design of packaging and labeling

Samples of designed package and label

(II) Pharmaceutical data

7. Summary of Pharmaceutical Study

Include the synthetic technics, formula selection, structure identification, quality study and establishing the quality standard, the summary of experiment and global literature of stability study.

8. Research information and relevant literature of the production process

Include process flow and chemical equations, the starting material and organic solvent, reaction conditions (temperature, pressure, time, catalysts and etc.) and operating steps, refining methods, the main physicochemical constants and periodically accumulated results of the data, the amount of the raw materials, yields and the impurities or other intermediates which was produced or