(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. Two sets of complete application dossiers (at least one set is in the original) and one set of review documents in hard copy shall be submitted for registration application, according to previous practices and actual situation. Four application forms (1 in the original and 3 in hard copy) shall be separately put into each set of dossier (the original application form and a hard copy shall be put in the set of the dossier in the original).
5. "Import Drug Registration Application Form": the drug registration application form submission program could be downloaded from CFDA website (www.cfda.gov.cn); the application form shall be filled in as required, printed and saved, and shall be signed by the overseas applicant, and signed & sealed by its domestic agent.
6. When mailing or submitting the application dossiers, the electronic version of the application form shall be sent to the e-mail address dedicated for drug registration
7. The data checking code on the electronic and paper application form should be identical.
8. Foreign language materials shall be translated into Chinese.
(II) Specific requirements for application dossiers :
1. The "Application Form for the Registration of Imported Drug" should be filled in an accurate and standardized manner in line with the requirements of explanatory notes:
(1) Drug Registration Category: fill in as per the corresponding article Annex I of the “Provisions for Drug Registration” (SFDA Order No. 28).
(2) Additional application: other applications can be raised at the same time, such as exemption from clinical trials, non-prescription drugs, etc.
(3) Specifications: where the drug for registration has multiple specifications, an acceptance number shall be designated for each specification in a separate application form.
(4) Packaging specifications: multiple packaging specifications shall be filled in one application form. Multiple package volumes and sizes of non-injectable formulations like agents, oral solutions, granules, ointments, eye drops, and pastes with the same drug formulations shall be subject to uniform management according to different packaging sizes, and filled in one application form.
(5) The applicant: on the application form, organization 1 and organization 2 refer to information of overseas licensed providers and production plant, these two items cannot be left blank. Except for the applicants in Hong Kong, Macao and Taiwan regions, the business name, address, etc. should be filled in English; Organization 3 refers to the information for overseas packaging plants which should be completed in accordance with the actual situation. Except for the applicants in Hong Kong, Macao and Taiwan regions, the business name, address, etc. should be filled in English; the relevant information of domestic agencies should be filled in Chinese.
(6) The information on the application form should be consistent with the proof documents as provided.
2. While there is a same product in observation period, the product as filed shall not apply for import registration.
3. Requirements for proof documents:
(1) 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; export certificate(s) issued by the biological species control authority of the exporting country. Proof documents issued by the manufacturing country or region
① shall be issued by drug administration departments of the manufacturing country or region (including the EU).
② The format of CPP (Certificate of a Pharmaceutical Product), which is issued by relevant drug regulatory authority of the manufacturing country or region for marketing authorization and GMP-compliance, shall be in line with the format recommended by WHO, if not so, the original copy of the notarization document(s) issued by the public notary office of the country of origin, and the certificate(s) issued by the Chinese Embassy in the country shall be simultaneously submitted.
③ The originals shall be provided. While hard copies are submitted, the original copy of notarization document(s) issued by the public notary office of the country of origin, and the original copy of the certificate(s) issued by the Chinese Embassy in the country shall be filed at the same time..
④ Government proof documents, notarial documents and certificates shall not be unpacked without permission.
⑤ The key information of the documents shall be consistent with the corresponding information filled in the application form, such as the exporting country, importing country, drug name, product name (especially foreign trade name), specification, status of whether or not approved for marketing or already marketed in the exporting country, certificate holder, and manufacturer etc.
⑥ All proof documents as provided must be within the validity period.
⑦ Application for international multi-center clinical study must provide GMP-compliance documents and proof of the drug’s Phase Ⅱ clinical trials issued by drug administration of the countries or regions of origin.
(2) 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.
(3) Description of the patents in China and their ownership status for drug for applications, or their prescription, technology, intended use, etc., as well as a statement of non-infringement to other patents.
(4) Copies of approval letters for research project of narcotic drugs, psychotropic substances and toxic drugs.
(5) Copies of "Drug packaging materials and containers registration certificate" or "Imported packaging materials and containers registration certificate" for packaging materials (or containers) in direct contact with the drugs.
(6) Safety testing data should provide the appropriate certificate of Good Laboratory Practice (GLP); clinical test samples should provide appropriate pharmaceutical GMP certificates.
(7) Other proof documents.
