Seven goals of the Chinese Pharmacopoeia to 2020

The Exposure Draft clarifies the seven specific goals of the 2020 edition of the Chinese Pharmacopoeia:

First, increase the collection of the species to meet the clinical needs

Adhere to the principle of selection of varieties that are commonly used clinically, with reliable curative effect, safe use, mature technology, and controllable quality, and comprehensively cover the national essential drug list and the national basic medical insurance drug list, and adapt to the needs of adjustment and change of clinical therapeutic drug guidelines; The collection of drugs, Chinese herbal medicines, and pharmaceutical excipients standards; the collection of new preparations should fully reflect the achievements of China's pharmaceutical innovation.

The total number of species to be included in the 2020 edition of the “Chinese Pharmacopoeia” is planned to reach about 6,400, among which there will be approximately 220 varieties of traditional Chinese medicines, 420 varieties of chemical drugs, 30 varieties of biological products, and 100 varieties of medicinal materials. There are 30 varieties of drug packaging materials, totaling about 800. The Pharmacopoeia has 1400 species plans to be revised, including 500 Chinese medicines, 600 chemical medicines, 150 biological products, and 150 medicinal excipients.

Second, in conjunction with the national drug standards clean-up, and gradually improve the drug standards elimination mechanism

Comprehensively clean up the country's existing drug standards and increase the elimination of drug standards that have been cancelled, long-term non-production, uncontrollable quality, unreasonable dosage forms, and low stability. The varieties that need to be evaluated for clinical value or risk effectiveness should be submitted to relevant departments for evaluation.

Third, improve the "Chinese Pharmacopoeia" standard system, strengthen the concept of the entire process of drug quality management

Further improve the quality control technical requirements for horizontal coverage of traditional Chinese medicines, chemical medicines, biological products, raw material medicines, pharmaceutical excipients, drug packaging materials, and reference materials, and further improve the general rules for the vertical coverage of pharmacopoeia, general rules for preparations, general principles, test methods, and guiding principles. Formulate and revise, and at the same time comply with the development trend of drug supervision, gradually strengthen and improve the construction of general technical requirements and guiding principles concerning drug R&D, production, circulation, and use, reflecting that the quality of drugs originates from design and depends on the whole process. Control security concept.

Fourth, to strengthen the "Chinese Pharmacopoeia" normative, and further promote the unified coordination between the pharmacopoeia

Enhance the standardization and harmonization of the contents of all pharmacopoeia departments, the harmonization of general-purpose technical requirements and relevant technical regulations, and the unification of general-purpose technical requirements with the contents of various ministries and the content of the various standards. Establish unified and standardized principles for naming generic names of pharmaceuticals, pharmaceutical excipients and drug packaging materials, study and formulate drug standard coding systems, and formulate pharmacopoeial terminology.

V. Improving the technical requirements for general use and comprehensively demonstrating the quality control of pharmaceuticals

It will closely follow the development trend of the international advanced pharmacopoeia standards, combine the actual practice of pharmaceutical production in China, further expand the application of advanced detection technologies, and focus on strengthening research and establishment of control methods for drug safety and effectiveness. Improve and strengthen the "Chinese Pharmacopoeia" general technical requirements of system revision work, give full play to the "Chinese Pharmacopoeia" standard normative and guiding role, as a whole to improve drug standards. Approximately 30 new testing methods were added, 20 new general rules and general principles were added, 15 new guiding principles were added, 60 test methods were revised and improved, 12 general rules and general principles were revised, and 10 guiding principles were adopted.

VI. Promoting the harmonization of paper standards and physical standards

Strengthen the communication and coordination with the Central Inspection Institute and the cooperation in division of labor. In the standard research and drafting process, we should do a good job of linking standard work, actively select and recommend candidates for standard products, and strive to introduce standards and standard products at the same time.

VII. Enhance the exchange and cooperation of drug standards and promote the coordination of international pharmacopoeia

Uniformly cooperated with WHO to establish a pharmacopoeia exchange system and a multinational pharmacopoeia comparison information platform to lay the technical foundation for promoting international pharmacopoeia coordination. To coordinate the work of the import and export trade of pharmaceuticals. By strengthening bilateral and multilateral international exchanges and cooperation, the international leading position of Chinese medicine standards will be highlighted, and the international influence of China Pharmacopoeia and Chinese pharmaceutical quality will be continuously expanded.