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Drugs
Review and issuance of approval documents for initial import (incl. from Hong Kong, Macao and Taiwan) of crude drugs
2013-12-06

I. Project name: Imported Drug Registration


II. Content of licensing: Review and issuance of approval documents for initial import (incl. from Hong Kong, Macao and Taiwan) of crude drugs


III. Legal basis: "Drug Administration Law," "Regulations for Implementation of Drug Administration Law", and the "Administrative Measures for Imported Crude Drugs (Interim)"


IV. Charges: RMB 2000yuan.
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:
Information No (1) "Application Form for Imported Crude Drugs"
Information No (2) Applicants “Drug Distribution License" or "Drug Production License", "Business License "(Photocopy);
Information No (3) Legal registration proof documents of the supplier (such as "Business License", etc.) (photocopy);
Information No (4) Purchase contract (copy);
Information No (5) Crude drugs’ quality standards and their sources;
Information No (6) Crude drugs’ source research supporting information (the research and proof information should be provided by institutions qualified for identification of the sources of animals and plants).

VII. Requirements for application dossiers:
(I) General requirements for application dossiers:
1. 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.
2. Submit a complete set of application dossiers.
3. "Application Form for Imported Crude Drugs": download from CFDA website (www.cfda.gov.cn), fill and print as required and save with the seal of the applicant and the signature of their legal representatives.
4. 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.
5. Foreign materials should be translated into Chinese.
6. All copies shall be stamped with the official seal of the applicant.

(II) Specific requirements for application dossiers:
1. "Application Form for Imported Crude Drugs" should be filled out in an accurate and standardized manner that conforming the described requirements.
(1) Approvals Classification: you can select only "one-time valid document."
(2) Quantity (kg): the quantity applied should be less than or equal to that recorded in the contracts.
(3) Inspection criteria: Applicants shall fill in according to the actual situation.
(4) Delivery Port: Fill in according to the relevant provisions of Article IV of the "Administrative Measures for Imported Crude Drugs (Interim)".
(5) Ports or border port (Food) and Drug Administration: Fill in according to the relevant provisions of Article III of the "Administrative Measures for Imported Crude Drugs (Interim)".
(6) The form shall be signed and sealed by the applicant as required.
2. Applicants “Drug Distribution License" or "Drug Production License", "Business License "(Photocopy).
Should be within the validity period, and the information of company name, address and legal representative shall be consistent with those recorded in the application form.
3. Legal registration proof documents of the supplier (such as "Business License", etc.) (photocopy).
Should be within the validity period, and the information of company name, address and legal representative shall be consistent with those recorded in the application form.
4. Purchase contract copy.
The information of the product, the name and address of the applicant and supplier company should be consistent with the corresponding content in the application form.
5. Crude drugs’ quality standards and their sources.
The information provided shall correspond with the "13 inspection standards" in the application form, and the content should be consistent with the "No.144 notice" or relevant quality standards (eg, ChP standards).
6. Crude drugs’ source research supporting information (the research and proof information should be provided by institutions qualified for identification of the sources of animals and plants).
Among them, if the quality standards for the imported medicines originate from the local standards of provinces, autonomous regions and municipalities, the applicant shall improve the standards and submit, in addition to the above information, related research data for improvement based on the specific cases. In case standard is not available, the applicant shall submit, in addition to the above information, the following information:
(1) Ecological environment, growth characteristics, morphological description, cultivation or plant (culture) technology, origin and processing of the herbs.
(2) Drafting instructions for drug quality standards.
(3) Review of pharmacology and toxicology research data.
(4) Pharmacodynamic study and literature data.
(5) Test data and literature in general pharmacology studies.
(6) Acute toxicity test data and literature.
(7) Information to prove that CN-approved patent TCM drugs contain the crude drugs under application.

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:
After the application is accepted by the Administrative Service Center, the applicant shall promptly submit the test samples and related information to the National Institute for Control of Pharmaceutical and Biological Products (NICPBP). After receiving the test samples and relevant information, the NICPBP shall complete sample test for initial application for crude drugs with existing legal standards, within 30 days; and for which without existing legal standards, complete quality standard review and sample inspection within 60 days; then submit to CFDA the inspection reports and review comments.


(III) Technical review and decision of administrative licensing:
After receiving the inspection reports and review comments of the NICPBP, CFDA shall complete the technical review and administrative review within 40 days.
During the review process, CFDA shall provide a comprehensive suggestion for supplementary information, if necessary.
The applicant shall submit within four months the appropriate supplementary information after receiving a Notice for additional information, an extent of 20 days on the basis of the original review time limit shall be given, withdrawal of review shall be applied to overdue supplementary information. The applicant must submit a written application to CFDA for supplementary information that cannot be submitted within the specified time limits due to force majeure, and explain the reasons.
CFDA shall respond within 20 days for the handling of such cases.


(IV) 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.


(V) Re-review:
With any objections to disapproval decisions made by CFDA, the applicant can submit a written application for re-review within 10 days upon receipt of the decision and elaborate the reasons.
The contents of the re-review shall be limited only to the original application items and the original application dossiers.
After receiving the application for re-review, CFDA shall re-review the application in accordance with the original time limits and requirements, and make a decision for re-review. If CFDA decides to cancel disapproval decision, the appropriate "Approval letter for imported drugs" shall be issued to the applicant; if the original decision is maintained, it shall no longer accept repeated application for re-review.
If the re-review calls for sample inspection or quality standards review, they shall be conducted in accordance with the original timelines and requirements.

X. Commitment time frame:
For initial import application for crude drugs with legal standards, decision of administrative licensing shall be made within 70 days as from the date of acceptance; for which without legal standards, decision of administrative licensing shall be made within 100 days as from the date of acceptance.
The above timeframe does not include the time for supplementary information.

XI. License validity:
The validity period for single-use approval documents is one year.

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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