The draft consists of seven chapters and 35 articles, mainly including general provisions, organizational management, planning, research and development, review and release, supply and application, and supplementary provisions. Regulations have been made on the full process management requirements for the development, supply, and application of national drug standard substances.
The draft states 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 drugs. National drug standard substances should have stability, uniformity, and accuracy. They are first level standard substances used for national drug standards that have been strictly measured and evaluated, 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. They have the highest level of accuracy and traceability in the industry. National drug standard substances include standard samples, reference materials, reference extracts, reference medicinal materials, and reference materials.
The draft explains the status and responsibilities of various parties in the development and management of drug standard substances, including the National Institute for the CNIFDC, provincial drug regulatory departments, the National Technical Committee and Secretariat for Drug Standard Substances, the National Pharmacopoeia Commission and the Drug Evaluation Center of the National Medical Products Administration, and national enterprises and institutions. The China National Medical Products Administration is responsible for the management of the development, supply, and application of national drug standard substances. Organize the planning, development, approval, release, supply, and coordination of national drug standard substances, as well as external communication and cooperation work, and organize capable units to participate in collaborative calibration of national drug standard substances.
According to the draft, the China National Medical Products Administration should strengthen the technical research and development and preparation capabilities of national drug standard substances, provide personnel, funding, and facility guarantees for the effective operation of the research, preparation, and supply of standard substances, and ensure the continuous and effective supply of national drug standard substances.
In addition, the draft points out that the Secretariat of the Standardization Committee shall formulate the annual first batch development or batch replacement development plan for national drug standard substances based on regulatory needs, pharmacopoeia promulgation, drug standard formulation and revision, and changes in the supply and demand of national drug standard substances. The batch numbers of national drug standard substances are uniformly compiled 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 substances should refer to national drug standards and relevant standard substance specifications and technical requirements at home and abroad, and establish a quality assurance system to ensure the quality of standard substances. The preparation principles of national drug standard substances can refer to the basic specifications of drug production quality management standards or other relevant international standards. The cleanliness, temperature, humidity, lighting, safety, etc. of the preparation environment should meet the requirements of 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 to ensure their stable quality. National drug standard substances involving hazardous chemicals, anesthetics, psychotropic drugs, precursor 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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