The first section of the imported drugs registration
Article eighty-fourth for the importation of drugs, shall obtain theapproval of overseas pharmaceutical manufacturers producingcountries or regions; not approved in the production of country or region, but by the State Food and Drug Administration confirmed that the drug safety, efficacy and clinical need, can approve the import.
Application for import of drugs, its production shall comply with thecountry or region where drug production quality management standards and China "drug production quality management standards" requirement.
Eighty-fifth shall apply for the registration of imported drugs,should fill out the "application form" drug registration, submit the relevant materials and samples, to provide the relevant documents, apply to the State Food and drug administration.
Article eighty-sixth the State Food and Drug Administration review the form of the application materials, to meet the requirements,issued a notification on acceptance of the application for drug registration, and notify the Chinese bio pharmaceutical products registered by the organization of the 3 production batches ofsamples were registered test; do not meet the requirements,issued by the drug registration application inadmissible notice,and explain the reasons.
The State Food and drug administration can be organized on the development and production of on-site inspection, and sample.
Eighty-seventh Chinese bio - pharmaceutical products registered by the received data and samples, shall within 5 days ofregistration inspection.
Eighty-eighth bear the imported drug registration inspection ofdrug inspection office received information, samples and relevantstandard substances, shall complete registration inspection within 60 days and the drug registration inspection report and submit to the China drugs and biological products inspection institute.
Sample inspection and drug standard review special drug andvaccine products shall be completed within 90 days.
The eighty-ninth China drugs and biological products assayreceived drug registration inspection report and review of theimported drugs have standards, should be in 20 days to organize experts to conduct technical review, when necessary, can be rereview according to the examination opinions.
Ninetieth Chinese bio - pharmaceutical products registered by theregistration of imported drugs inspection after completion, should be reviewed drug standard, drug registration inspection reportand review opinions to the State Food and Drug AdministrationCenter, and send a copy of the applicant.
Article ninety-first the State Food and drug administration center should be within the time stipulated in the organization ofpharmaceutical, medical and other technical staff to review the declaration materials, when necessary, may request the applicant to provide supplementary materials, and explain the reasons.
Article ninety-second the State Food and Drug AdministrationCenter for drug evaluation on the basis of the technical review opinions and sample testing results, the formation of the comprehensive, together with the relevant information to the State Food and drug administration, the State Food and Drug Administration on the basis of the comprehensive, make adecision on examination and approval. In conformity with the provisions, issued a "drug clinical trial approval"; not in conformity with the provisions, to the "approval notice", and explain the reasons.
Ninety-third clinical trial is approved, the applicant shall, in accordance with the provisions of chapter third tests and related requirements.
Clinical after the test, the applicant shall fill in "application form"drug registration, clinical trial data submitted in accordance with the provisions and other changes and additional information, and explains the basis and reasons, to provide the relevant documents.
Article ninety-fourth the State Food and drug administrationcenter should be clinical trial data organization of pharmaceutical,medical and other technical personnel within the time specified in the comprehensive review, when necessary, may request the applicant to provide supplementary materials, and explain the reasons.
The State Food and Drug Administration on the basis of the comprehensive, make a decision on examination and approval. In conformity with the provisions, to "the drug import registration certificate". China Hongkong, Macao and Taiwan regions of thepharmaceutical manufacturers to apply for registration of drugs,shall be handled with reference to the application of drug import registration procedures, to meet the requirements, issued a"registration certificate" pharmaceutical products; do not meet the requirements, to the "approval notice", and explain the reasons.
Article ninety-fifth for imported drugs, the legitimate sources ofpackaging materials and containers must provide a direct contact with drugs, the documents used in the production ofpharmaceutical raw materials and excipients in the formulation of legal sources of the documents. Raw materials and auxiliary materials have not yet obtained the approval of the State Food and drug administration, research data should be submitted to the relevant production technology, quality requirements and testmethods specification.
The second section of drug import registration points packaging
Ninety-sixth repackaging of imported drugs, refers to the drug has completed final preparation production process in the overseas, in the territory of the packaging specifications into small packaging,or packaging of the completed within the drug packaging,brochures, stickers and other place.
Article ninety-seventh apply for repackaging of imported drugs,shall meet the following requirements:
(a) the drug has made "card" registration of imported drugs orpharmaceutical product registration certificate "";
(two) the drug shall be China has not yet produced a variety of, or even though the production but can not meet the clinical need variety;
(three) the same cultivars in same pharmaceutical manufacturersshall be repackaged by a pharmaceutical producing enterprises,sub packaging shall not exceed "the drug import registration certificate" or "certificate of registration" pharmaceutical productsis valid;