"Chinese Pharmacopoeia" 2020 edition of the outline of the preparation of fresh, first look!

[editor's point of view of chinapharma.com] on January 30, 2018, the National Pharmacopoeia Committee issued the notice on the preparation of the outline of Chinese Pharmacopoeia 2020 This work was launched at the 11th founding meeting and the plenary session of the Pharmacopoeia Committee last year On the basis of considering the overall situation of national drug standards, it is estimated that there will be about 6400 varieties and 800 new varieties in 2020 edition of Chinese Pharmacopoeia, including about 220 new varieties of traditional Chinese medicine, 420 new varieties of chemical medicine, 30 new varieties of biological products, 100 new varieties of auxiliary materials for medicine and 30 new varieties of drug packaging materials There are 1400 revised varieties, including 500 traditional Chinese medicine, 600 chemical medicine, 150 biological products and 150 pharmaceutical excipients From the above data, in the 2020 edition of Chinese Pharmacopoeia, there will be a large number of chemical drugs, a considerable number of traditional Chinese medicine varieties, and an increase in biological products It is conducive to the adjustment of drug structure Industry insiders predict that the 2020 edition of China Pharmacopoeia will moderately increase the collection of varieties, which will be conducive to the research and establishment of drug safety and effectiveness control methods In combination with the national drug standard cleaning, the elimination mechanism of drug standards will be gradually improved, the standard system will be improved, and the whole process management concept of drug quality will be strengthened From the compilation outline of Chinese Pharmacopoeia 2020 edition, we can see eight specific tasks That is to say, the collection of varieties should be moderately increased to further meet the clinical needs; the elimination mechanism of drug standards should be gradually improved in combination with the cleaning up of national drug standards; the standard system of China Pharmacopoeia should be improved to strengthen the concept of the whole process management of drug quality; the standardization of China Pharmacopoeia should be strengthened to further promote the unified coordination among all Pharmacopoeia departments; the general technical requirements should be improved to fully display Drug quality control level; promote the coordination and unification of paper standards and physical standards; strengthen international exchange and cooperation of drug standards, promote international coordination of Pharmacopoeia standards; strengthen informatization construction of Pharmacopoeia standards, and constantly enrich standard service forms In recent years, China's pharmaceutical industry has developed rapidly, but there is still a certain gap compared with the quality and efficacy of drugs in the United States, Japan and other countries The main reason is that the standard of drug listing is not high enough and the implementation is not in place In addition, in terms of the quality of traditional Chinese medicine and decoction pieces, China has also become a serious disaster area in recent years In 2020, China Pharmacopoeia has a large number of new varieties The use of new analysis technology and detection equipment is conducive to improving the quality control level of drugs and ensuring the safety of public drug use Generally speaking, the task of establishing pharmacopoeia standard is long However, with the promotion of the standardization of Chinese pharmacopoeia in 2020, the elimination mechanism of drug standards will be gradually improved, and the quality level of drugs will be further improved The compilation of the 2020 edition of the Chinese pharmacopoeia is in the period of the implementation of the 13th five year plan for national economic and social development It is the key period for China to build a healthy China and achieve the goal of building a moderately prosperous society in an all-round way It is also the key period for China to build an innovative country and a large pharmaceutical country An important stage to become a pharmaceutical power It is of great significance to carry out the action of improving drug standards and to work out the new edition of Chinese pharmacopoeia for ensuring the safety and effectiveness of public drug use and promoting the upgrading of pharmaceutical industry and product quality II Guiding ideology and overall goal: fully implement the spirit of the 18th National Congress of the Communist Party of China, take the establishment of "rigorous standards" as the guidance, firmly establish the five development concepts of "innovation, coordination, green, opening and sharing", closely focus on the overall goal of the 13th five year plan for national drug safety, and take clinical needs as the guide Guide, compare with international advanced standards, improve and eliminate the combination, further improve the construction of drug standard system with Chinese Pharmacopoeia as the core, improve the overall level of Chinese pharmacopoeia standard, after five years, make the formulation of Chinese pharmacopoeia standard more rigorous, the selection of varieties more reasonable, more coordinated with international standards, and the standard formation mechanism more scientific We will continue to lead the development of international standards by striving to realize the standards of traditional Chinese medicine The standards of chemical drugs and pharmaceutical excipients basically reach or are close to the international standards The standards of biological products keep pace with the forefront of scientific and Technological Development and are basically consistent with the international advanced level Three, the basic principles (1) to enhance the quality of drugs, ensure the safety of drugs, and effectively adhere to the scientific, advanced, practical and normative drug standards, promote the quality of drugs, and ensure the safety and effectiveness of public medication (II) encourage technological innovation and promote the application of research results Adhere to the combination of inheritance and innovation, encourage the innovation of drug testing methods, improvement of production process and quality control technology, so that more scientific research results can be transformed and applied in drug standards (3) adhere to the principle of "survival of the fittest" and promote the adjustment of product structure Increase or decrease in the income of Pharmacopoeia varieties, optimize the increment and reduce the stock; give full play to the standard guiding role of China Pharmacopoeia, and promote the adjustment of industrial structure and the upgrading of products (IV) promote reform, improve the standard formation mechanism, improve the national drug standard formation and elimination mechanism, focus on highlighting the leading role of the government in the formulation of national standards and the dominant position of enterprises in the formulation of product standards, and take active incentive policies and measures to guide the society and industry to increase human, material and financial resources We should devote ourselves to the research and development of standards and build a new pattern of drug standard work (5) to strengthen the support of standards, to serve the supervision and administration of drugs, and to improve drug standards, we should focus on the reform of drug review and approval system, and cooperate with and support the development of key work Adhere to regulatory basis standards and standard service supervision Guided by problems, we should closely integrate the formulation and revision of drug standards with drug consistency evaluation, safety evaluation of traditional Chinese medicine injection, sampling inspection of drug quality evaluation, monitoring of adverse drug reactions, and drug re registration, so as to form positive interaction, information sharing, coordination and promotion, and promote the improvement of regulatory capacity 4 Specific objectives (1) moderately increase the collection of varieties to further meet the clinical needs Adhere to the selection principle of "commonly used clinically, accurate efficacy, safe use, mature technology, and controllable quality", comprehensively cover the national essential drug catalog and national essential medical insurance drug catalog, and adapt to the needs of adjustment and change of clinical treatment drug guidelines; Emphasis should be placed on the collection of standards for APIs, Chinese herbal medicines and pharmaceutical excipients, and the collection of new preparations should fully reflect the achievements of pharmaceutical innovation in China The total number of varieties collected in 2020 edition of Chinese pharmacopoeia is planned to reach about 6400, including about 220 new varieties of traditional Chinese medicine, 420 new varieties of chemical drugs, 30 new varieties of biological products, 100 new varieties of pharmaceutical excipients and 30 new varieties of drug packaging materials, totaling about 800 1400 varieties have been revised in the Pharmacopoeia, including 500 traditional Chinese medicines, 600 chemical drugs, 150 biological products and 150 pharmaceutical excipients (II) gradually improve the elimination mechanism of drug standards in combination with the national drug standard cleaning up Comprehensively clean up the existing national drug standards, and increase the elimination of drug standards that have cancelled the document number, have not been produced for a long time, have uncontrollable quality, unreasonable dosage form and have low stability For the varieties that need to be evaluated on clinical value or risk benefit, they shall be submitted to relevant departments for evaluation (III) improve the standard system of the Chinese Pharmacopoeia, strengthen the concept of the whole process management of drug quality, further improve the technical requirements for quality control of traditional Chinese medicine, chemical medicine, biological products, APIs, pharmaceutical excipients, drug packaging materials and reference materials, and further improve them It vertically covers the formulation and revision of the general principles, general principles, inspection methods and guiding principles of Pharmacopoeia Meanwhile, it complies with the development trend of drug supervision and gradually strengthens and improves the construction of general technical requirements and guiding principle system involving drug research and development, production, circulation and use, reflecting that drug quality comes from design and depends on the whole process control The concept of security (IV) strengthen the standardization of the Chinese Pharmacopoeia, further promote the unified coordination among all departments of the Pharmacopoeia, strengthen the standardization of the contents of each department of the Pharmacopoeia, the coordination and unification of the general technical requirements and relevant technical regulations, and the unification of the general technical requirements and the contents of each department as well as the contents of each standard Establish unified and standardized naming principles for common names of drugs, pharmaceutical excipients and drug packaging materials, study and formulate drug standard coding system and pharmacopoeia terminology (V) improve the general technical requirements, fully demonstrate the level of drug quality control, closely follow the development trend of international advanced Pharmacopoeia standards, further expand the application of advanced detection technology in combination with the actual pharmaceutical production in China, and focus on strengthening the research and establishment of control methods for drug safety and effectiveness We will improve and strengthen the preparation and revision of the general technical requirements of the Chinese Pharmacopoeia, give full play to the normative and guiding role of the standards of the Chinese Pharmacopoeia, and improve the overall level of drug standards About 30 testing methods, 20 general rules and general comments, 15 guiding principles, 60 testing methods, 12 general rules and general comments, and 10 guiding principles were added (VI) promote the coordination and unification of paper standards and physical standards; strengthen the communication and coordination with the Chinese Academy of inspection and division of work cooperation; do a good job in the connection of standard work in the process of standard research and drafting, actively select and recommend standard candidates, and strive for the simultaneous promotion of standards and standards (7) strengthen the exchange and cooperation of drug standards, promote the coordination and unification of International Pharmacopoeia, and work with who to establish the Pharmacopoeia exchange mechanism and the Multi Country Pharmacopoeia comparison information platform, so as to lay a technical foundation for promoting the coordination of International Pharmacopoeia Carry out standard coordination work guided by the demand of drug import and export trade 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 Chinese Pharmacopoeia and Chinese medicine quality will be continuously expanded 5 Key work of each department (1) one traditional Chinese medicine (TCM) establishes TCM quality control technology system and TCM standard guided by TCM clinical practice In terms of safety: effectively control the impact of exogenous pollutants on the safety of traditional Chinese medicine, comprehensively formulate the limit standards for heavy metals, harmful elements and pesticide residues in traditional Chinese medicine, decoction pieces, and comprehensively formulate the limit standards for mycotoxins in easily moldy traditional Chinese medicine and decoction pieces To effectively control the influence of endogenous toxic components on the safety of traditional Chinese medicine, focus on the prediction and evaluation methods of hepatorenal toxicity in line with the characteristics of traditional Chinese medicine, and formulate the test standards and guiding principles for the safe use of traditional Chinese medicine In terms of effectiveness: strengthen the specificity and integrity of TCM standards, and constantly innovate and improve TCM analysis and test methods Focus on the research of biological evaluation and measurement methods based on the clinical efficacy of traditional Chinese medicine, and explore the establishment of a standard system that can reflect the efficacy of traditional Chinese medicine as a whole by combining morphology, microscopy, chemical components and biological effects (II) safety formula of two chemicals