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    Home > Chemial News > Pharma News > The 2020 edition of the Chinese Pharmacopoeia has came out

    The 2020 edition of the Chinese Pharmacopoeia has came out

    Echemi 2020-07-03

    The 2020 edition of the Chinese Pharmacopoeia contains 5,911 species, an increase of 5.5% compared with the 2015 edition of 5,608.

      
    A total of 2711 kinds of traditional Chinese medicines are included, of which 117 kinds are newly added and 452 kinds are revised. The second part contains 2712 kinds of chemical drugs, of which 117 kinds are newly added and 2387 kinds are revised. The three parts of biological products contain 153 kinds, of which 20 kinds are newly added and 126 kinds are revised; 2 general rules of newly added biological products and 4 in general. The four parts contain 361 general technical requirements, including 38 general rules for preparations (revised 35), 281 test methods and other general rules (newly added 35, revised 51), and 42 guidelines (newly added 12, revised 12) ); 335 kinds of medicinal excipients are collected, of which 65 kinds are newly added and 212 kinds are revised.

      
    It is understood that the first edition of "Chinese Pharmacopoeia" has been promulgated since 1953, and so far the country has promulgated 11 editions of Pharmacopoeia. The 2020 edition of "Chinese Pharmacopoeia" contains a total of 5,911 species, of which 319 are newly added, 3177 are revised, 10 are no longer included, and 4 species are adjusted and combined. A total of 2711 kinds of traditional Chinese medicines are included, of which 117 kinds are newly added and 452 kinds are revised. The second part contains 2712 kinds of chemical drugs, of which 117 kinds are newly added and 2387 kinds are revised. The three parts of biological products contain 153 kinds, of which 20 kinds are newly added and 126 kinds are revised; 2 general rules of newly added biological products and 4 in general. The four parts contain 361 general technical requirements, including 38 general rules for preparations (revised 35), 281 test methods and other general rules (newly added 35, revised 51), and 42 guidelines (newly added 12, revised 12) ); 335 kinds of medicinal excipients are collected, of which 65 kinds are newly added and 212 kinds are revised.

      
    At the "Eleventh Pharmacopoeia Commission Executive Committee Meeting", Jiao Hong, chairman of the 11th Pharmacopoeia Commission and director of the State Food and Drug Administration, pointed out that the 2020 edition of "Chinese Pharmacopoeia" steadily promotes the collection of pharmacopoeia varieties, which further meets the national basic Demand for drug catalogs and basic medical insurance catalog varieties. The national drug standard system is becoming more and more perfect, the level of drug standards has been significantly improved, the requirements for drug safety have been continuously strengthened, and the guiding role has become increasingly significant. Its promulgation and implementation will help to improve the overall level of my country's pharmaceutical standards, further ensure the safety of public medication, promote the adjustment of the pharmaceutical industry structure, promote the internationalization of my country's pharmaceutical products, and realize the leap from a major pharmaceutical country to a powerful pharmaceutical country.


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    In China, the "Chinese Pharmacopoeia" is the "threshold standard" for drug registration approval. Regardless of whether it is a domestic or foreign enterprise, the quality standards of the drugs developed in my country should meet the relevant technical requirements of the Chinese Pharmacopoeia.

      
    The newly revised "Administrative Measures for Drug Registration", which came into effect on July 1, stipulates that drugs should meet the national drug standards and the drug quality standards approved by the State Drug Administration. The drug quality standards approved by the State Drug Administration are drug registration standards. The drug registration standards shall comply with the general technical requirements of the Chinese Pharmacopoeia, and shall not be lower than the provisions of the Chinese Pharmacopoeia.


    Lan Fen, Secretary-General of the National Pharmacopoeia Commission, said that this compilation took the opportunity of implementing the "two laws" to comprehensively improve the pharmacopoeia system and strengthen the concept of full-process management of drug quality: it has improved the horizontal coverage of traditional Chinese medicine, chemical drugs, biological products, and raw materials. The technical requirements for quality control of medicines, pharmaceutical excipients, pharmaceutical packaging materials and standard materials; and the formulation and revision of vertical coverage of pharmacopoeia general rules, general rules of preparations, inspection methods and guiding principles; and at the same time, strengthened the development and production, quality control of pharmaceuticals , Circulation and use of the general technical requirements system.
     

    The National Drug Standard is a mandatory provision made by the state to ensure drug quality, guide drug researchers and drug marketing license holders to do drug R&D and post-market drug quality control, and to control drug quality control items, technical indicators, and inspection methods. . "Chinese Pharmacopoeia" is an important part of the national drug standard and the core of the national drug standard system. The preparation of the 2020 edition of the pharmacopoeia fully implements the "four most stringent" requirements, conforms to the industry development laws, and is guided by clinical needs. It appropriately increases the number of pharmacopoeia included varieties, reflects the full life-cycle quality management of drugs, improves the drug standard system, and strengthens Significant progress has been made in controlling the safety and effectiveness of drugs, expanding the application of mature analysis and testing technologies, guiding industrial development and innovation, and strengthening coordination with international drug standards. The promulgation and implementation of the new version of the Pharmacopoeia will certainly play an important role in ensuring the quality of drugs, maintaining public health, and promoting the high-quality development of the pharmaceutical industry.

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