I. Project name: Registration of pharmaceutical excipients
II. Content of licensing: registration renewal for import (incl. from Hong Kong, Macao and Taiwan) of pharmaceutical excipients
III. Legal basis: "Drug Administration Law of the People's Republic," "Regulations for Implementation of Drug Administration Law", "Notice on the Issuance of Requirements for Registration Application of Pharmaceutical Excipients" (SFDA Department of drug registration  letter No.61)
IV. Charges: RMB 45300yuan.
Charging basis: "Notice of The National Development and Reform Commission and the Ministry of Finance on the Adjustment of Fees for Drug Review, Approval and Tests" [J.J.G. (1995) No.340]
V. Quantity restrictions: No quantity limit for the licensing
VI. List of application dossiers:
"Application form for registration renewal of Drug"
1. Proof documents.
(1) Copies of "Imported Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate", and CFDA approval documents for supplementary application;
(2) Proof documents, notarized documents and Chinese translations issued by drug regulatory authorities of the country or region of origin to permit the marketing and sales of pharmaceutical excipients and to prove the GMP-compliance of the manufacturers as well as the DMF of APIs
(3) For applications performed by overseas excipients manufacturers鈥? Permanent Representative in China, the applicant should provide a copy of the "Registration certificate of permanent Chinese representative offices of foreign enterprises ".
(4) For entrustment of Chinese agencies engaged in application, Overseas manufacturer of excipients shall provide the commission documents, notarized documents and their Chinese translations, as well as copies of Chinese agencies鈥? "Business License"
2. Summary report of imports and sales in China within five consecutive years, and explanations for disqualified cases.
3. A summary of the application and adverse reactions of pharmaceutical excipients preparations within five years
4. For unaccomplished matters as required by the drug approval documents or renewal approval documents, the applicant should provide summary reports, together with the corresponding data.
5. Provide the prescription, production processes, and quality standards of pharmaceutical excipients. If the prescription, production processes or quality standards have changed as compared to the content of the last registration, the specific alterations shall be indicated with appropriate approval and proof documents
6. Sample manuscript of minimum packaging unit for marketing of pharmaceutical excipients, labels and packaging insert.
VII. Requirements for application dossiers:
(I) General requirements for application dossiers:
1. The first page of the application dossiers should be the catalog for application items, which shall be arranged in order of the "letter on the issuance of requirements for registration application dossiers of pharmaceutical excipients". Each data shall indicate on the cover: pharmaceutical excipients name, data item number, item name, contact name, phone, and address of the applicant.
2. The dossiers should use A4 size paper for print or copy, the content should be complete, standardized and clear; shall not be altered, the data must be real and reliable.
3. The dossiers shall be loaded in portfolio in full set, the portfolio envelope shall indicate: Application classification, registration classification, pharmaceutical excipients name, the portfolio鈥檚 X Set, X envelope, original / copy, the contact person, telephone, registration application agency name.
4. Registration applications shall submit two sets of complete application dossiers (including one set of originals, one set of copies), 3 copies of the Application form (1 originals and two copies) shall be enclosed into the various sets of dossiers (1 originals and 1 copy of the application form in the full original dossiers).
5. "Application Form for the Registration of Imported Drug ": download from CFDA website (www.cfda.gov.cn) the offer procedures of drug registration application), fill in as required, save and print the document, which must be signed by overseas applicants, and stamped and signed by domestic agencies.
6. Along with the submission or mail of the application dossiers, their electronic version shall be sent to the Administrative Service Center by e-mail. e-mail address: [email protected].
7. The data verification code of the electronic application forms should be consistent with paper application forms.
8. Foreign materials should be translated into Chinese.
(II) Specific requirements for application dossiers:
1. The "Application Form for the Registration of Imported Drug" should be filled in an accurate and standardized manner in line with the requirements of explanatory notes:
(1) Except for the changes, the rest of the contents should be consistent with the drug approval documents; the content of any changes (if any) should be indicated.
(2) Drug Registration Category: should be "pharmaceutical excipients."
(3) Formulation type: "non-preparation excipients."
(4) Specifications: separate specification and acceptance number shall be designated for each registration application form.
(5) Whether to apply for supplementary application items: If you select "Others", the specific contents of the supplemental application should be described in the "Other Special Notes".
(6) Applicant: the entries of institution 1 and 2 on the application form refer to foreign licensed provider and manufacturer information, these two cannot be vacant. business name, address, etc. shall be filled in English, except for the applicants from Hong Kong, Macao and Taiwan regions; institution 3 refers to overseas packaging plant information, which should be completed in accordance with the actual situation, business name, address, etc. shall be filled in English, except for the applicants from Hong Kong, Macao and Taiwan regions; Items of domestic agencies must be filled in Chinese.
(7) The information on the Application form should be consistent with those provided in the proof documents.
2. Copies of "Imported Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate", and CFDA approval documents for supplementary application;
3. Proof documents, notarized documents and Chinese translations issued by drug regulatory authorities of the country or region of origin to permit the marketing and sales of pharmaceutical excipients and to prove the GMP-compliance of the manufacturers as well as the DMF of APIs
(1) The proof documents issued by the drug administration authorities of the country or region of origin, which permit the marketing of the pharmaceutical excipients and prove the GMP compliance of the manufacturers of pharmaceutical excipients, shall meet the unified format specifications recommended by the World Health Organization.Files in other formats must be notarized by public notary organizations of the country of origin and certified by Chinese embassies and consulates in the country.
(2) If the excipient is not yet permitted for marketing in the country or region of origin, the applicant can provide the documents proving its marketing in other countries or regions, as well as the DMF (Drug Master File) information documents of APIs, notarized documents and Chinese translations, which shall be submitted to CFDA for approval. However, the documents proving GMP compliance of pharmaceutical excipients manufacturers must be provided by the pharmaceutical excipients regulatory institutions in country or region of origin.
(3) The applications for medicinal hollow capsules, gelatin capsules, and pharmaceutical gelatin derived from imported bovine pharmaceutical excipients are required to provide the proof documents of the sources and types of the main raw material for preparing capsules-gelatin, and provide government documents which prove the raw material were from BSE non-involved country.
(4) Government proof documents, certificates, and notarized documents shall not be opened without authorization.
(5) Itemized review should be conducted for major information of the exporting country, the importing country, pharmaceutical excipients name, specifications, marketing approval and sales status in the exporting country, licensed providers, manufacturers etc., which should be consistent with the corresponding information listed in the Application form.
(6) The documents provided shall be within the validity period (if any).
Contact: Peter Zhang
Email: [email protected]
Add: No.24566 Jingshi Road Huaiyin District Jinan City, Shandong Province,China