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