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Drugs
Examination & approval for CFDA-recorded supplementary application for imported drugs (incl. from Hong Kong, Macao and Taiwan)
2013-12-06

I. Project name: Imported Drug Registration


II. Content of licensing:
The classification of CFDA-recorded supplementary application for imported drugs (incl. from Hong Kong, Macao and Taiwan) shall follow the supplementary application item 21, 23, 24, 25, 26, 27, 28 and 29 in Annex IV of the "Provisions for Drug Registration", namely:
21 Changes of packaging materials or containers in direct contact with drugs (except for supplementary application item 10 approved by CFDA).
23 Changes in the production place of APIs for imported drugs and preparations.
24 Change the appearance of imported drugs, but do not change the drug standards.
25 Modify the package inserts of imported drugs in accordance with the requirements of national drug standards or CFDA provisions.
26 Supplement and improve the safety section in imported drugs’ package inserts.
27. Change the package labels of imported drugs as required.
28. Changes in drug registration application agencies for imported drugs.
29. Others

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. Fees: No charge


V. Quantity restrictions: No quantity limit for the licensing

VI. List of application dossiers:
"Supplementary Application Form for Imported Drugs"
Data number (1) Copies of proof documents for drug approval and the annex:
Including all approval documents related to the application, such as drug registration approval document, supplementary application approval document, trade name approval documents, standards promulgation documents, drug standard revision approvals, drug approval number uniform renewal approvals, "Registration Certificate for Imported Drugs "," Registration Certificate for Pharmaceutical Product "and so on. The Annex includes the attachments of the above-mentioned approval documents, such as drug standards, package inserts, packaging labeling sample and other attachments.
Data number (2) Proof documents:
(1) 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.
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;
(2) For different application items, relevant proof documents shall be separately provided according to the "Form of items of application dossiers".
(3) For imported drugs, the applicant shall submit the proof documents issued by drug regulatory institutions of the manufacturing country or region to permit alterations of drugs, their notarized documents and Chinese translations.
The format of these documents shall conform to the requirements of related proof documents in the application dossiers items for TCM, natural medicine, chemicals and biological products
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.
Data number (3) sample manuscript of revised package insert, along with a detailed description of revisions.
Data number (4) Sample manuscript of revised drug packaging labels, together with a detailed description of revisions.
Data number (5) Pharmaceutical research information:
According to the different requirements for registration items, some or all of the pharmaceutical research data and necessary dossiers of the original registration application shall be provided separately in accordance with the items provided in Annex 1 to 3.
Data number (6) Pharmacology and toxicology research data:
According to different requirements for registration items, some or all of the pharmacology and toxicology research data and necessary domestic and overseas research literature shall be provided separately in accordance with the items provided in Annex 1 to 3
Data number (7) Clinical trials data:
If clinical trials are needed, item-specific application dossiers shall be submitted separately before and after the clinical trials, it should be in accordance with the items provided in Annex 1 to 3. If clinical trials are not required, relevant clinical trial research data can be provided.

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.


3. The documents shall be put in portfolio envelope(s), on which the application classification, registration category, drug name, the envelope number of set X, the total number of envelopes in the set, original or copy, the contact person, phone number and the name of registration application agent shall be indicated.


4. 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


5. 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.


6. Chinese translations should be provided as required for foreign materials.


7. The historical approval documents and attachments of the product shall be provided according to the instructions of proof documents for drug approval as stated in Annex IV of the "Provisions for Drug Registration". For supplementary application prior to the completion of approval procedures for registration renewal, the applicant shall specify the relevant renewal application in the "Drug Supplementary Application Form", and provide a copy of the notice on acceptance of the renewal application

8. The applicant shall provide copies of the registration certificate of foreign enterprises’ resident representative office in China. If the application is performed by Chinese domestic enterprises or agencies entrusted by foreign pharmaceutical manufacturers, the applicant shall provide the entrustment documents, notarized documents and their Chinese translations.

9. The applicant shall submit the proof documents issued by drug regulatory authorities of the manufacturing country or region to permit alterations of drugs, and their notarized documents and Chinese translations. The format of these documents shall conform to the requirements of related proof documents in the application dossiers items for TCM, natural medicine, chemicals and biological products. If the drug regulatory authorities of the manufacturing country or region cannot provide relevant proof documents, explanations shall 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.

(II) Specific requirements for application dossiers:
1 Modify the package insert in accordance with national drug standards or China Drug and Drug Administration:
(1) Provide new national drug standards or documents issued by CFDA requiring modification of package inserts of drugs.
(2) Sample manuscript of revised package insert, along with a detailed description of revisions.


2 Enrich and improve the safety precautions in package insert of drugs:
(1) Allows only the enrichment of adverse reactions, contraindications, and precautions, and renewal of pharmacology and toxicology, pharmacokinetics items. Does not include the increase of application scope such as indications or functions, usage, dosage and other items.
(2) Sample manuscript of revised package insert, along with a detailed description of revisions.


3 Modifying drug packaging label:
(1) Relevant provisions and documents shall be provided for change of drug packaging labels as required
(2) Sample manuscript of revised drug packaging labels, together with a detailed description of revisions.


4 Change the agencies for registration of imported drugs: provide the entrustment documents from overseas pharmaceutical manufacturers to new Chinese drug registration agencies, notarized documents and their Chinese translations, copies of the business license of the new drug registration agency in China; certificates of overseas pharmaceutical manufacturers’ rescission of the originally registered principal-agent relations, the corresponding notarized documents and their Chinese translations.

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.


(IV) Decision of administrative examination & approval:
Upon receipt of the record information, CFDA shall make the decision 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:
The administrative licensing decision shall be made within 20 days from the date of acceptance. (Note: 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:
No approval documents for licensing

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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