The tenth drug registration (hereinafter referred to as the applicant), refers to the application for registration of the drugsand bear the corresponding legal responsibility mechanism.
A domestic applicant should be and can bear civil liabilities independently legally registered within the territory of China, an overseas applicant shall be a legal overseas drug manufacturer.Overseas applicants for registration of imported drugs, agency within China shall be composed of its offices in the territory of China or its authorized.
For the application for drug registration affairs personnel shall have the corresponding professional knowledge, familiar with thelaws, regulations and technical requirements for registration of pharmaceuticals.
Applications include applications for new drugs, generic drug applications, application for imported drugs and its supplementary application and registration of eleventh drug registration.
A domestic applicant to apply for registration of drugs, genericdrug application in accordance with the procedures and requirements for an overseas applicant, apply for the registration of imported drugs shall be handled in accordance with the procedures and requirements of application for imported drugs.
Twelfth new drug application, refers to the application that haven't been marketed within the territory of China's drug registration.
The drugs already on the market, change the form to change the route of administration, adding new indications of drug registrationin accordance with the new drug application program.
Generic drug applications, the application of production refers tothe State Food and Drug Administration approved national standards for drug registration; but the biological products in accordance with the new drug application procedure declaration.
Application for imported drugs, refers to the registered foroverseas products marketed in China.
Supplementary application, is a new drug application, andas or import drug is approved, apply changes, increase or cancel the original approval matters or the contents of the register.
Application for registration again, refers to the drug approval documents after the expiration of the applicant intends to apply forproduction or import the drug registration.
Thirteenth the applicant shall provide sufficient and reliable research data, that the drug safety, effectiveness and quality control, and the authenticity of all the information for the.
Article fourteenth drug registration materials submitted shall indicate the name of publications, citations publication name andvolume, page, etc.; unpublished documents shall provide the dataowner licensing documents. Foreign materials Chinese translation shall be provided in accordance with the requirements of.
Article fifteenth the State Food and drug administration shallimplement the national pharmaceutical industry developmentplanning and industrial policy, can organize the market value on the drug evaluation.
Article sixteenth drug registration process, the pharmaceutical supervisory and administrative department shall be of non clinical research, clinical trials, on-site verification for verification andapproval, production site inspection before the listing, the authenticity, accuracy and integrity of the data to confirm the declaration.
Seventeenth where two or more units to the applicant, shall apply to the drug production enterprises of the province, autonomous region, or municipality directly under the central government and drug supervision and administration department; applicants for drug production enterprise, an application shall be submitted to the drugs production enterprise for production preparation of the province, autonomous region, or municipality directly under the central government and drug supervision and managementdepartment; applicants are not the drugs production enterprise,an application shall be submitted to the trial site local province,autonomous region, or municipality directly under the central government and drug supervision and administration department.
Eighteenth the applicant shall apply for registration of the drugs or the use of prescription, process, application, provide the applicantor others in Chinese patent and ownership status description;others have patent in China, the applicant shall submit to thepatent does not constitute infringement claims. For the applicant to submit explanation or statement, the pharmaceutical supervisory and administrative departments shall be published on the agency website.
Patent dispute process in the drug registration, in accordance with the relevant laws and regulations to solve the patent.
Nineteenth of the people have obtained Chinese patent drugs, the applicant may in the patent expires 2 years prior to application for registration. The State Food and Drug Administration in accordance with the present Measures shall be subject to the examination, in accordance with the provisions of the patent expires, after the issuance of a drug approval number, "the drug import registration certificate" or "pharmaceutical product registration certificate".
Article twentieth in accordance with the "Drug Administration LawImplementation Rules" in article thirty-fifth, to obtain the production or sale of drugs containing new chemical compoundslicense submitted by the manufacturer or seller to obtain andundisclosed experiment data and other data, the State Food and Drug Administration approved within 6 years from the date ofapproval, did not agree on the applicant has obtained the licenseto use the non disclosure of data, the application will not beapproved; however, the applicant submitted to obtain data except.
Article twenty-first for drug clinical application of drug registrationbefore the study, including the synthesis process of medicine,extraction, physicochemical properties and purity, choice of dosage form, the prescription, preparation, inspection method,quality index, stability, pharmacological, toxicological, animalpharmacokinetic study. Study on the preparation of traditional Chinese medicine also includes raw material sources, processing and processing; biological products including bacterium, cells,tissue, starting the source of raw materials, quality standards,preservation condition, biological characteristics, genetic stabilityand immunology research.