The Eleventh Conference of the Chinese Pharmacopoeia Commission Executive Committee Held in Beijing — Review and Approve the Draft of ChP 2020 Edition
Pursuant to the Charter of the Chinese Pharmacopoeia Commission and the compilation procedures of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as ChP), on April 9, the 11th Conference of the Chinese Pharmacopoeia Commission (ChPC) Executive Committee was held in Beijing for a briefing on ChPC's compilation of the ChP 2020 Edition, as well as the deliberation and approval of its draft. Jiao Hong, NMPA Commissioner and Chairperson of the 11th ChPC, and Zeng Yixin, ChPC Deputy Chairman and Vice-minister of the National Health Commission attended the Conference and delivered speeches. Chen Shifei, NMPA Deputy Commissioner and ChPC Deputy Chairman, chaired the Conference. Lan Fen, Secretary General of ChPC, briefed to all executive committees on the compilation of the ChP 2020 Edition.
ChP 2020 Edition has 319 new admissions, 3,177 revisions, 10 exclusions (rejections), 4 combination adjustments, and a grand sum of 5,911 monographs. Volume I-TCM contains a total of 2,711 monographs, covering 117 new admissions and 452 revisions. Volume II-Chemicals contains 2,712 monographs, covering 117 new admissions and 2,387 revisions. Volume III-Biologicals contains 153 monographs, covering 20 new admissions, 126 revisions; and 2 new General Requirements for biological products and four General Monographs. Volume IV contains 361 General Technical Requirements, covering 38 General Requirements for preparations (incl. 35 revisions), 281 detection methods and other General Requirements (35 new admissions, 51 revisions), and 42 guidelines (12 new admissions, 12 revisions); and 335 monographs of medicinal excipients, including 65 new admissions and 212 revisions.
Jiao pointed out that ChP 2020 Edition is steadily advancing the inclusion of pharmacopoeia monographs, which further meets the needs of the National Essential Drug List 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 of ChP has become increasingly significant. The promulgation and implementation of ChP 2020 will help to raise the overall level of China's pharmaceutical standards, further ensure the protection of drug safety for the public, motivate the adjustment of the pharmaceutical industry structure, and facilitate China's pharmaceutical products to go global, aiming at a leap from a big country with numerous small pharmaceutical enterprises to a big country with strong pharmaceutical enterprises.
Jiao emphasized that the national drug standard is a mandatory provision made by the state on drug quality indicators and inspection methods to ensure drug quality, and a legal technical requirement that must be followed in drug production, distribution, use and supervision. The newly revised Drug Administration Law further aggrandizes the legal role of the national drug standard. It is necessary to continuously consolidate the legal status of ChP, reinforce the drug standard system and management capacity building, comprehensively improve the overall level of the national drug standard, and effectively promulgate and implement the new ChP, to ensure that it is well understood, implemented and supervised.