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Registration renewal for import of pharmaceutical excipients (incl. from Hong Kong, Macao and Taiwan)
2013-12-06

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 [2005] 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’ 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’ "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’s 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: slzx@cfda.gov.cn.
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).


4. If the registration renewal merges multiple supplementary applications, it is required to submit the proof documents or DMF information and documents issued by drug regulatory authorities of the manufacturing country or region which allow the alterations.


5. The application shall be submitted six months before the expiry date of the approval document. Reregistration application after the expiry date shall be rejected.

VIII. Diagram of application procedures:

IX. Licensing procedures:
(I) Acceptance:
After the Application is made to the Administrative Service Center, and the application dossiers submitted in order listed in Article VI of this "TIPS", the work staff shall review the format. If the application items are not subject to administrative examination and approval according to law, the decision of non-acceptance shall be immediately made. If the application items are not within the purview of the executive authorities, the decision of non-acceptance shall be immediately made and the applicant shall be informed to apply to related administrative institutions; .If the application dossiers have errors that can be corrected on the spot, the applicant shall be allowed to correct on the sport; if the application dossiers are incomplete or do not meet the statutory form, the applicant should be informed in full to enrich or rectify the relevant contents on the spot or within five days. If they are not informed, the application dossiers shall be deemed accepted from date of receipt. If the application dossiers are within the scope of the administrative institutions, the application materials are complete and comply with the statutory form, or the applicant has submitted all application materials in accordance with the requirements of the administrative authorities for enrichment or correction, the application shall be accepted for administrative examination and approval.


(II) Drug registration inspection (if needed):
After the Administrative Service Center accepted the application, CFDA shall inform NIFDC of registration testing, approval decision or other affairs related to the review, which should be completed within 30 days from the date of acceptance.
NIFDC shall organize sample tests and standards review within a timeframe of 85 days, which is in parallel with CFDA inspection and CDE technical review, the specific timeframe is allocated as follows:
NIFDC shall designate related drug control institutions to conduct registration inspection within five days upon receipt of the application dossiers and samples. Drug control institutions undertaking the registration inspection for imported drugs shall complete the registration inspection within 60 days upon receipt of the application dossiers, samples and standard substances and submit the drug registration inspection test report to NIFDC. After receiving the drug registration inspection test report and imported drug registration standards that have been reviewed, NIFDC shall organize experts to perform technical review within 20 days, and if necessary, re-review shall be conducted according to review comments.


(III) Technical review:
Along with the drug registration inspection, CFDA Administrative Service Center shall deliver the application data to CDE for technical review.
CDE shall complete the technical review in accordance with the related principles in 180 days. After the completion of the technical review, if the dossiers do not meet the technical review requirements of CDE, a notice for supplementary information shall be issued to the applicant for additional information submitted within four months. CDE shall complete the review of the supplementary dossiers in no more than 60 days


(IV) Administrative licensing decision:
After receiving the CDE technical review data, CFDA shall make the decision for licensing within20 days. If a decision cannot be made within 20 days, an extension of 10 days may be granted upon approval of competent CFDA leaders.


(V) Delivery:
Within 10 days from the date of decision making of administrative examination and approval, CFDA Administrative Service Center shall deliver the decision to the applicants.


(VI ) Re-review:
With any objections to decisions made by CFDA, the applicant can fill in within 60 days upon receipt of the decision the "Application Form for Drug Registration Re-review" to apply for re-review and elaborate reasons, before the application for administrative reconsideration or an administrative lawsuit. The contents of the re-review shall be limited to only the original application items and the original application dossiers.
After receiving the application for re-review, CFDA shall make a decision for re-review within 50 days and notify the applicants. If the original decision is maintained, CFDA shall not accept the application for reconsideration again.
If the reconsideration needs a technical review, CFDA shall organize relevant professional and technical personnel to conduct the review according to the original application timeframe.

X. Commitment time frame:
The decision for administrative licensing shall be made within 200 days from the date of acceptance (CFDA shall complete the examination and approval within 20 days after completion of the technical review; if CFDA failed to so, an extension of 10 days can be granted upon consent of the competent CFDA leaders).
The above timeframe does not include the time for supplementary information and the corresponding review.

XI. License validity and renewal:
The CFDA-issued drug approval number, "Imported Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate" shall be valid for five years. If production or import are still necessary upon expiry of the certificate, the applicant shall apply for renewal six months before the expiry.

XII. Authority of implementation:
Authority of implementation: CFDA
Location for acceptance: CFDA Administrative Service Center

XIII. Annual inspection or annual review of the license: None


XIV. Institutions for inquiries and complaints:
Inquiries: CFDA
Complaints: CFDA Bureau of Investigation and Enforcement, Department of Legal affairs
Note: The time frame of this TIPS counts on working days, excluding legal holidays

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