Measures of the state for the administration of pharmaceutical reference materials
Article 1 In order to further regulate the management of national drug reference materials, the measures are formulated according to the relevant provisions of the drug administration law of the people's Republic of China, the measures for the administration of drug registration and the measures for the administration of the registration of in vitro diagnostic reagents (for Trial Implementation).
Article 2 The calibration, examination and approval of national drug reference materials and the external supply of national drug reference materials shall comply with these measures.
Article 3 National drug reference materials refer to the materials or substances that are used for physical and chemical tests and biological method tests in national drug standards, have certain characteristic quantities, and are used to calibrate equipment, evaluate measurement methods, or assign values to test drugs.
National drug reference materials are divided into biological standards, biological reference materials, chemical reference materials, reference medicinal materials / reference extracts, medical device reference materials and standards, in vitro diagnostic reagent standards, pharmaceutical excipients reference materials and drug packaging materials reference materials.
Article 4 The National Institutes for food and drug control (nifdc) (hereinafter referred to as "the Chinese Academy of inspection") is responsible for conducting a comprehensive review of the calibrated drug reference materials from the aspects of raw material selection, preparation methods, calibration methods, calibration results, accuracy of fixed value, traceability of quantity value, stability, sub packaging and packaging conditions, cost, etc., and making a conclusion whether they can be used as national drug reference materials.
Article 5 The Chinese Academy of inspection has set up a reference material management office, which is responsible for the integration, organization, coordination and management of national drug reference materials. The Chinese Academy of inspection has set up a national drug reference material Committee, which is responsible for the comprehensive technical review of national drug reference materials and the review of relevant technical guidance specifications.
Article 6 The reference materials management office is responsible for organizing the declaration and acceptance of the new drug reference materials in the drug registration application and the revision of drug standards. The declared drug reference materials and their research materials shall meet the requirements of the national measures for the declaration and filing of drug reference materials and the raw materials of drug reference materials of relevant categories.
Article 7 The raw materials of national drug reference materials shall meet the requirements of national drug standards, and the reference materials management office shall be responsible for organizing the preparation or procurement of relevant varieties of raw materials. For pharmaceutical reference materials required by special sources, raw materials that meet the requirements of national pharmaceutical standards can be obtained by means of self preparation and collection from relevant institutions or specific groups. For the varieties with insufficient supply of raw materials of pharmaceutical reference materials or difficult to obtain, the reference materials management office shall summarize them and submit them to relevant units, and submit them to the State Food and Drug Administration for coordination and settlement.
Article 8 The calibration and valuation methods of national drug reference materials shall comply with the requirements of the national drug standards, the technical specifications for national drug reference materials issued by the Chinese Academy of inspection and the valuation methods of specific types of reference materials.
Article 9 The office for the control of certified reference materials may organize competent drug control institutes, research institutions, manufacturers and other units to collaborate in the calibration of national drug reference materials.
Article 10 According to international practice, the national drug reference materials do not have a validity period, but the stability of characteristic quantities should be checked regularly under the specified storage and use conditions.
Article 11 The change of batch number, suspension and cancellation of varieties of national drug reference materials shall be approved by the national drug reference materials Committee, and the reference materials management office shall publish them to the public in a timely manner.
Article 12 The packaging of national pharmaceutical reference materials shall be suitable for the quality of pharmaceutical reference materials and convenient for storage, transportation and use. The reference material preparation room is responsible for the sub packaging and packaging of pharmaceutical reference materials. For the varieties that need to be sub packaged and packaged by units outside the hospital, the reference material management office and the preparation room shall organize the corresponding review and approval.
Article 13 The package of national drug reference materials shall be labeled and attached with operation instructions to provide users with the following information: name, number, batch number, purpose, characteristic value, storage conditions, use method and precautions.
Article 14 The service center for reference materials is responsible for organizing the external supply of national pharmaceutical reference materials. The specific implementation shall be organized according to the national standard for supply management of pharmaceutical reference materials.
Article 15 National drug reference materials involving narcotic drugs, psychotropic drugs, toxic drugs for medical use and pathogenic microorganisms shall be managed according to relevant laws and regulations, and the requirements for purchase and use shall be specified.
Article 16 The cost of national drug reference materials shall be calculated by the development department according to the pricing scheme of national drug / biological product / medical device reference materials, reviewed by the reference materials management office and approved by the national drug reference materials Committee.
Article 17 Personnel participating in the calibration, packaging and review of national drug reference materials must keep the relevant technical information and data confidential.
Article 18 The measures shall be interpreted by the reference material management office.
Article 19 These Measures shall be implemented as of October 1, 2011. The national measures for the administration of pharmaceutical reference materials (for Trial Implementation) promulgated in 2009 shall be abolished at the same time.