Chinese(GB)     
Contact CFDA
   
HOME ABOUT CFDA WHAT'S NEW LAWS & REGULATIONS REGULATORY GUIDE DATA SEARCH SITE MAP
  Search      
Home >> Regulatory Guide  
Drugs
Registration renewal of imported drugs (incl. pharmaceutical products from Hong Kong, Macao and Taiwan)
2013-12-06

I. Project name: Imported Drug Registration


II. Content of licensing: Registration renewal of imported drugs (incl. pharmaceutical products from Hong Kong, Macao and Taiwan)


III. Implementation basis: "Drug Administration Law," "Regulations for Implementation of the Drug Administration Law,” and “Provisions for Drug Registration”, "Notice on Matters Relating to the Renewal of Imported Drugs " (SFDA Department of drug registration [2009] No.18)


IV. Charges:
Review and approval fee for imported drugs: RMB45,300yuan
Charging basis: "Notice of the State Planning 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 of drug registration renewal"
Data number (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 issued by relevant drug regulatory authority of the manufacturing country or region for marketing authorization and GMP-compliance, as well as their notarization documents and Chinese translations;
3. Proof documents issued by drug regulatory authorities of the manufacturing country or region to permit alterations of drugs, notarized documents and their Chinese translations thereof;
4. Where a foreign manufacturer’s representative office in China deals with the registration issues, copies of Registration Certificate of Resident Office of Foreign Enterprise shall be provided;
5. Where a foreign manufacturer authorizes a domestic enterprise or agency for the registration issues, copies of the authorization letters with notarized documents and the Chinese translation as well as the Business License of the domestic enterprise or agency shall be provided.
Data number (2) Summary report of imports and sales in China within five consecutive years, and explanations for disqualified cases.
Data number (3) Summary report of clinical application and ADR conditions within five years after drug import and sales.
Data number (4) Additional information or explanations shall be provided for any of the following circumstances in renewal application:
1. For necessary phase IV clinical trials,a summary report should be provided;
2. 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.
Data number (5) Provide prescriptions of medicines, production technology, drug standards and testing methods. For any changes of drug formulations, production process, drug standards and testing methods as compared to the previous registration, the specific alterations shall be indicated and accompanied with approval documents.
Data number (6) Sources of APIs for production of drug formulations Changes of the API sources shall provide the proof and approval documents.
Data number (7) Real samples of the packages, labels and package inserts of smallest sales unit in Chinese market.
Data number (8) Current original package inserts issued by drug regulatory authorities of the manufacturing country or region and their Chinese translations.

VII. Requirements for application dossiers:
(I) General requirements for application dossiers:
1. The first page of the dossiers shall be a directory for application items, which shall be arranged in order as per Annex I of the “Provisions for Drug Registration” (SFDA Order No. 28). Each dossier shall indicate on its cover: the name of the drug and application item, document item number, and the name, phone number and address of contact person and the applicant.
2. All documents in the dossier shall be printed or copied in A4 size paper. The content shall be complete, standardized, clear, without alteration, and the data must be real and reliable. The dossiers shall be put in portfolio in full set, the portfolio envelope shall indicate: Application classification, Registration Category, drug name, the portfolio’s X Set, X envelope, original / copy, the contact person, telephone, registration application agency name.
3. Please submit two sets of complete application dossiers (including one set of originals, one set of copies), 3copies of the application form (1 original, two copies), which shall be enclosed separately into the portfolios
4. Please download the Drug Registration Application Form and the Application Form for Developing the Offer Program via www.cfda.gov.cn, the electronic version shall be sent to slzx@cfda.gov.cn mailbox along with the mail or delivery of application dossiers.
5. Chinese translations should be provided as required for foreign materials.

(II) Specific requirements for application dossiers:
1. " Application form of drug registration renewal":
(1) Download from CFDA website (www.cfda.gov.cn) the drug registration application form and submission procedures, fill out the form as required, print and save it with signatures of foreign enterprises, and the signatures and seals of domestic agencies
(2) The drug name, specifications, validity, import pharmaceutical companies, manufacturers, and other information, if not changed, shall be consistent with the corresponding information in the "Imported Drug Registration Certificate " or "Pharmaceutical Product Registration Certificate" and CFDA approval documents for supplementary application.
(3) Item 23 of the application form should specify the contents of supplementary application, for example, if the application complies with the registration verification procedures as stipulated by Item 1 of Article 2 in the "Notice on issues related to the registration renewal of imported drugs", the applicant shall indicate the relevant alterations in the "Matters otherwise noted" section of the " Application form of drug registration renewal " and indicate that "this application meets the requirements for verification procedures for registration renewal" .
(4) If supplementary application has been submitted before renewal, and CFDA has not yet completed the examination & approval, the applicant shall explain the circumstances in the " Application form of drug registration renewal ", and submit a copy of the Acceptance notice for related supplementary application, CFDA shall accept the renewal application and perform the examination & approval in accordance with the contents of the original approvals.


2. Proof documents:
(1) The applicant shall provide the proof documents issued by drug regulatory authorities of the manufacturing country or region to permit the marketing of drugs and to prove the GMP compliance of the manufacturers, and their notarized documents and Chinese translations, the requirements for which is the same as those for registration application.
(2) If registration renewal merges supplementary application, the applicant is required to submit the proof documents issued by drug regulatory authorities of the manufacturing country or region to permit alterations of drugs, notarized documents and their Chinese translations.
A. The Format shall conform to the requirements for relevant proof documents as stated in Application information section of TCM, natural medicine, chemicals and biological products
B. If the drug regulatory authorities of the manufacturing country or region cannot provide relevant proof documents, explanations should be made according to the rules of the local laws and regulations, except for changes of drug specifications, the origin, the name and registered address of the pharmaceutical manufacturers.
(3) The applicant should provide copies of the "Registration Certificate of Foreign Enterprise’s Resident Office in China", and "Business license" of registered agencies; if the registered agencies are changed, the applicant shall provide the original certificates of overseas pharmaceutical manufacturers’ rescission of the originally registered principal-agent relations, which must be notarized at a local public notary organization.


3. Other dossiers shall be attached in accordance with the requirements of Annex V of the "Provisions for drug administration"


4. The applicants may apply for verification procedures for registration renewal for following imported drugs:
(1) While applying for registration renewal, no changes have occurred for drug prescriptions, production processes, quality standards, API sources, packaging materials in direct contact with the drugs, package inserts and labels, etc.; or the supplementary applications for changes occurred have been approved or filed by CFDA in accordance with the "Provisions for Drug Registration";
(2) Changes of the names and addresses of enterprises, production plants, and drug names etc. that involve no technical review;
(3) Enrichment or improvement of the safety precautions of the package inserts;
(4) Shortened validity period of drugs;
(5) Other issues that are directly recorded by CFDA.


5. The following supplementary application shall not be applied together with registration renewal:
(1) Change of origin;
(2) Additional drug specifications.


6. The Drug Standards Information submitted by the applicant for registration renewal of imported drugs should include internal control standards of the enterprise.

VIII. Application process diagram:
Eligible to the application for verification procedures in registration renewal:
Process I


Do not meet the verification procedures in registration renewal:
Process II


IX. Licensing procedures:
(I) Acceptance:
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center. Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately. Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application dossiers. Where the application dossier is within the functions of the administrative authority, the application dossiers are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.


(II) Drug registration inspection (if required):
After the Administrative Acceptance Service Center accepting the application, CFDA shall inform NIFDC to conduct registration inspection, determine issues related to the approval or review, which shall be completed within 30 days from the date of acceptance.
NIFDC has a time limit of 85 days to test samples and review the standards, and a time limit of 115 days for inspection of special drugs and vaccine products, the time frame for NIFDC inspection is in parallel with that for CFDA examination and CDE technical review, and the specific time frame is allocated as follows:
After receiving information and samples, NIFDC shall arrange drug control institutions to conduct registration test within five days. The competent drug control institutions shall complete the registration inspection within 60 days from the receipt of dossiers, samples and related standard substances and submit the report to NIFDC; the sample tests and re-review of drug standards for special drugs and vaccine products can be completed in 90 days. After receiving the registration test reports and imported drug registration standards, which have been reviewed, the technical review shall be carried out by experts within 20 days; if necessary, re-review shall be conducted as per the review comments.


(III) Technical review:
Along with drug registration, Administrative Acceptance Service Center shall transfer the application dossiers to CFDA Center for Drug Evaluation for overall technical review.
CDE of CFDA shall complete the technical review within 180 days in accordance with the technical review principles. After the completion of the technical review, for disqualified applications, CDE shall issue a notice for supplementary information to the applicant, who shall supplement the information within four months, and CDE shall complete the review of the supplementary information in no more than 60 days.
The verification for dossiers of registration renewal shall be undertaken by NIFDC. Who shall complete the verification of the original files within 40 working days after receipt of registration application dossiers transferred by CFDA Administrative Acceptance Service Center, and submit the files together with renewal application dossiers to CFDA Department for Drug Registration.


(IV) Decision of administrative examination & approval:
After receiving CDE’s completed technical review data, CFDA shall make licensing decisions within 20 days. If a decision cannot be made within 20 days, and extension of 10 days can be granted with competent leader’s consent.


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


(VI) Review:
For disagreements of CFDA decision, the applicant can, prior to administrative reconsideration or administrative litigation, explain the reasons and apply for re-review to CFDA within 60 days from the date of receipt of the decision. 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 within 50 days and notify the applicant. If the original decision is maintained, CFDA shall no longer accept repeated application for re-review.
If the re-review requires technical re-review, CFDA should organize relevant professional and technical personnel to perform the re-review within the original application time limits.

X. Commitment of time frame:
Registration renewal applications in sketch map I: the decision for administrative licensing shall be made within 60 days from the date of acceptance (CFDA shall complete the examination & approval within 20 days after completion of the technical review; if CFDA failed to do so, an extension of 10 days can be granted with competent leaders’ consent).
Registration renewal applications in sketch map II: the decision for administrative licensing shall be made within 200 days from the date of acceptance (CFDA shall complete the examination & approval within 20 days after completion of the technical review; if CFDA failed to do so, an extension of 10 days can be granted with competent leaders’ consent).
The above time frames do not encompass the time required for the applicants to supplement information and the re-review of supplementary information.

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. Upon expiry of these certificates, if the production or import is still necessary, the applicant shall apply for renewal within six months before expiry.

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


XIII. Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Acceptance Service Center

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

HOME | ABOUT CFDA | WHAT'S NEW | LAWS AND REGULATIONS | REGULATORY GUIDE | DATA SEARCH
| SITE MAP |
© CFDA
Constructed and Maintained by the Information Center of CFDA