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Drugs
Examination and approval examination & approval for temporary import of drugs (incl. from Hong Kong, Macao and Taiwan)
2013-12-06


I. Project name: Temporarily Imported Drug Registration


II. Content of licensing: Examination & approval for Temporary import of drugs (incl. from Hong Kong, Macao and Taiwan)


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

IV. Charges: Approval charges RMB2,000 yuan


V. Quantity restrictions: No quantity limit for the licensing


VI. List of application dossiers:
"Application Form for Imported Drug Approval Document"
Data number (1) Application report for temporarily imported drugs
Data number (2) A copy of "Acceptance notice of drug registration renewal"
Data number (3) Copies of Original drug approval documents and attachments
Data number (4) Copies of approval documents for temporary import (if any)
Data number (5) Other relevant information


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.Please submit a full set of application dossiers.


(II) Specific requirements for application dossiers:
1. "Application Form for Imported Drug Approval Document"
(1) Download from CFDA website (www.cfda.gov.cn) the application form, which shall be filled out, saved and printed, and stamped with the official seal of the applicant's unit.
(2) The drug name, specifications, importing companies, manufacturers, and other information 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.
2. Application Report for Temporarily Imported Drugs shall provide the reasons and basis for temporary import, and the information whether there have been significant safety events and safety hazards in the past five years, whether the drug regulatory authorities of any countries have suspended or stopped the marketing of this drug or released significant safety alerts; whether the manufacturer has been published or is being investigated for violation of any national drug administrative laws, rules, regulations and relevant provisions.
3. The copy of "Acceptance notice of drug registration renewal" shall be stamped with official seal of the applicant's unit.
4. Copies of the Original drug approval documents and attachments stamped with official seal of the applicant's unit.
5. If the drug has received the approval documents for temporary import, a copy shall be attached and stamped with official seal of the applicant's unit.

VIII. Application process diagram:

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) Decision of administrative examination & approval:
CFDA shall complete the examination & approval for temporary import applications in 20 working days, if the requirements are met, the "Approval letter for imported drugs" shall be issued (attached table 2). If the requirements are not met, CFDA shall issue a "Notice of approval opinions. "The maximum time limit of the "Approval documents for import of drugs" is six months, within this limit, the specific import time limit shall be decided according to the registration renewal progress (such as two months, three months, etc.


(III) 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.


(IV) 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.

X. Commitment of time frame:
The administrative licensing decision shall be made within 20 days from the date of acceptance.
The above time limit does not include the time required for the applicant to supplement information.

XI. License validity and renewal:
The maximum time limit of the "Approval letter for imported drugs" is six months, within this limit, the specific import time limit shall be decided according to the registration renewal progress (such as two months, three months, etc.). Prior to the acquisition of new "Imported Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate," each application for registration renewal should, generally, apply for no more than 2 times of temporary import.

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

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