Content of licensing :
Review of supplementary application of imported drugs (incl. from Hong Kong, Macao and Taiwan), including supplementary application item2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 16, 17 and 18 as listed in Annex IV of the "Provisions for Drug Registration", namely:
Application item 2, Trade name of drugs
Application item 3, For enrichment of approved indications of TCM, chemicals and biological products in China
Application item 4, Change dosage or alter the scope of applicable population, but do not change the route of administration
Application item 5, Alteration of drug specifications
Application item 6, Change excipients that are required in pharmaceutical prescriptions
Application item 7, Changes in production processes that affect the quality of medicines
Application item 8, Modifying drug registration standards
Application item 9, Alternative or cancellation of toxic or endangered medicinal herbs that are listed in the national drug standard prescriptions
Application item 10, For imported drugs, domestically produced injections, ophthalmic preparations, aerosols, dry power inhalation, sprays that change the packaging materials or containers in direct contact with drugs; or using new packaging materials or containers in direct contact with drugs
Application item 11, Application for drug combination packaging
Application item 13, Revise or enrich the package inserts of TCM and natural medicine, such as the items of pharmacology and toxicology studies, clinical trials, pharmacokinetics etc.
Application item 14, Change the registered item of registration certificate for imported drugs, such as drug name, manufacturers name, registered address, drug validity, packaging specifications etc.
Application item 15, Changes of the origin of imported drugs
Application item 16, Changes in foreign packaging plants for imported drugs
Application item 17, Imported drugs repackaging in China
Application item 18, Others
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, notarized documents and Their Chinese translations issued by drug regulatory institutions of the manufacturing country or region to permit alterations of drugs. 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.
