In order to further improve the management of national drug standard substances, on December 22, the China Academy of Food and Drug Control (hereinafter referred to as the Institute) publicly solicited opinions on the draft Measures for the Management of National Drug Standard Substances. The public solicitation of opinions was completed as of January 20, 2024.
The draft consists of seven chapters and thirty-five articles, mainly including general provisions, organizational management, planning, research and development, review and release, supply and application, and supplementary provisions. Provisions have been made for the full process management requirements of the development, supply, and application of national drug standard substances.
The draft points out that national drug standard substances refer to substances used for physical, chemical, and biological testing of drugs in national drug standards, with determined characteristics or quantities, for calibrating equipment, evaluating measurement methods, assigning values to test drugs, or identifying substances. National drug standard substances should have stability, uniformity, and accuracy. They are first level standard substances that have been rigorously measured and evaluated for use in national drug standards, or second level biological, antibiotic, and other standard substances that can be traced back to the World Health Organization (WHO) or international first level standard substances, with the highest level of accuracy and traceability in the industry. National drug standard substances include standard substances, reference substances, reference extracts, reference medicinal materials, and reference substances.
The draft explains the status and responsibilities of various parties in the development and management of drug reference materials, including the Chinese People's Procuratorate, provincial drug regulatory departments, the National Technical Committee and Secretariat of Drug Reference Materials, the National Pharmacopoeia Commission and the Drug Evaluation Center of the National Medical Products Administration, and national enterprises and institutions. The Chinese People's Procuratorate is responsible for the management of the development, supply, and application of national drug standard substances. Organize the planning, research and development, approval and release, supply and coordination of national drug standard substances, as well as external exchange and cooperation work, and organize capable units to participate in collaborative calibration of national drug standard substances.
According to the draft, the Chinese People's Procuratorate should strengthen the technical research and development and preparation capabilities of national drug reference materials, provide personnel, funding, and facility guarantees for the effective operation of the research, preparation, and supply of reference materials, and ensure the continuous and effective supply of national drug reference materials.
In addition, the draft points out that the Secretariat of the Standardization Committee shall formulate the annual first batch development or replacement development plan for national drug standard substances based on regulatory needs, pharmacopoeia promulgation, drug standard formulation and revision, and changes in supply and demand of national drug standard substances. The batch number of national drug standard substances shall be uniformly prepared by the Secretariat. The batch number of national drug standard substances consists of the national drug standard substance number, year number, and batch number.
The draft also points out that the development of national drug standard materials should refer to the national drug standards and relevant domestic and foreign standard material specifications and technical requirements, and establish a quality assurance system to ensure the quality of standard materials. The preparation principles of national drug reference materials can refer to the basic specifications of drug production quality management standards or other relevant international standards. The cleanliness, temperature, humidity, light, safety, etc. of the preparation environment should meet the requirements of the relevant varieties.
National drug standard substances should be packaged, transported, and stored according to quality requirements such as physical and chemical properties or biological characteristics, and organized for storage to ensure their stable quality. National drug standard substances involving hazardous chemicals, psychotropic drugs, easily producible drugs, toxic drugs for medical use, and pathogenic microorganisms should be strictly managed and transported in accordance with relevant national laws and regulations.
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