Article 2 Generic drugs refer to the varieties that have been officially produced with the approval of the generic drug countries and registered in the national drug standards (including China's Regulations on Biological Products). The test standards and varieties of drugs under state administrative protection shall not be copied. Analysis Report on the Operating Data of Pharmaceutical Manufacturing Enterprises in China in 2008
2009-20 12 China Traditional Chinese Medicine Industry Investment Analysis and Prospect Forecast Report
Article 3 An enterprise applying for generic drugs must be an enterprise or workshop that has obtained the License for Pharmaceutical Manufacturing Enterprises and the GMP Certificate for Drugs.
Article 4 The quality of generic drugs shall not be lower than that of generic drugs, and their instructions for use shall be consistent with those of generic drugs.
Article 5 The State encourages innovation and technological progress, controls the examination and approval of generic drugs, and provides guidance through information release. For varieties that have met the clinical needs, the acceptance and approval of generic drug applications can be suspended. However, enterprises that significantly reduce costs or improve quality may still apply for imitation after being approved by the State Administration of Pharmaceutical Products.
Article 6 Any enterprise applying for generic drugs must first fill in the Application Form for Quasi-generic drugs and send it to the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government (hereinafter referred to as the provincial drug supervision and administration department) for preliminary examination, and the provincial drug supervision and administration department shall report it to the State Medical Device Administration for approval before trial production can be carried out and declaration can be made according to procedures.
Article 7 Declaration and approval of generic drugs
(1) An enterprise applying for generic drugs shall, after obtaining the approval from the State Administration of Pharmaceutical Products for trial production and completing the relevant technical work, submit a formal application to the provincial pharmaceutical supervisory and administrative department, fill in an application form for generic drugs, provide the Pharmaceutical Production Enterprise License (photocopy), GMP certificate (photocopy), the audit opinions of the State Administration of Pharmaceutical Products on generic drugs, and submit relevant technical materials. Human bioequivalence test shall be applied at the same time.
(2) The pharmaceutical supervisory and administrative department at the provincial level shall check the Pharmaceutical Production Enterprise License and GMP certificate of the enterprise or workshop applying for production, and decide to accept the application after confirming that the drugs applied for production by the enterprise or workshop meet the approved production scope and conditions.
(three) the provincial drug supervision and administration department is responsible for the evaluation of the production site (focusing on the source of samples, the existence of corresponding production equipment, quality testing instruments, trial production records, inspection records, etc.). ), and issue an evaluation report.
(four) the provincial drug supervision and administration department shall, after receiving the notice of generic drug inspection, conduct on-site sampling of three consecutive batches of samples produced by the applicant enterprise, and issue an inspection report. Application for imitation of biological products, by the China Institute for the control of pharmaceutical and biological products is responsible for sampling inspection.
(five) where the bioequivalence test is needed, it must be approved by the provincial drug supervision and administration department.
(6) After completing the examination, the provincial drug supervision and administration department shall fill in the examination opinions on the generic drug application form, and submit the License for Pharmaceutical Manufacturing Enterprise (photocopy), GMP Certificate for Drugs (photocopy), inspection report of drug inspection institute and relevant application materials in triplicate to the State Administration of Medical Devices.
(7) After examination and approval by the State Administration of Pharmaceutical Products, it is agreed that the approval number of generic drugs is unified, and the first four digits after the letter "f" in the approval document number are public year numbers.
Article 8 Applications for imitation of narcotic drugs, psychotropic drugs, drug rehabilitation drugs and radioactive drugs shall be handled in accordance with these Measures, except as otherwise provided by national laws and regulations.
Article 9 Any chemical that has national standards and is not within the protection period of a new drug, if there are significant changes in the process, shall be declared as generic drugs.
Article 10 Anyone who practices fraud in the trial production, application materials and sample provision of generic drugs will stop the examination and approval of generic drugs, and be dealt with according to the Measures of the State Administration of Pharmaceutical Products for Handling Violations in Drug Research, Application and Registration.
Article 11 An enterprise whose drug approval number has been revoked due to violation of the Drug Administration Law of People's Republic of China (PRC) will no longer accept its application for imitation of this variety within five years.
Article 12 Pharmaceutical excipients (except hollow capsules) applying for the production of national drug standards shall be examined and approved by the provincial drug supervision and administration department and reported to the State Medical Device Administration for the record.
Article 13 An enterprise applying for generic drugs shall pay the examination and approval fees in accordance with the relevant provisions of the state.
Article 14 The State Administration of Pharmaceutical Products shall be responsible for the interpretation of these Measures.
Article 15 These Measures shall be implemented as of 1 May, 19991day. If the provisions on the examination and approval of generic drugs previously promulgated conflict with these measures, these measures shall prevail.
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