The 2020 edition of the Pharmacopoeia is expected to receive 6400 drugs

  • Author:Jane
  • Source:ZHIYAO
  • Release on :2017-09-07
The "People's Republic of Pharmacopoeia China" 2015 edition is the tenth edition of the Pharmacopoeia since the foundation of the People's Republic of China. The pharmacopoeia of the People's Republic of China, which will be introduced in 2020, is currently being reviewed. The Secretary-General of the pharmacopoeia of the State Commission Zhang Wei stressed that the new pharmacopoeia to improve and enrich the connotation of pharmaceutical standards, strengthen control of the process, control of the drug terminal for the production process and the source control of Extension, to achieve the drug lifecycle standard quality control system.

Zhang Wein, Secretary-General of the State commission of the Pharmacopoeia, stated that the 11th edition of the Pharmacopoeia of the People's Republic of China, which will be introduced in 2020, should contain about 6400 varieties, 800 new varieties and 1,400 magazines variety.

Zhang Wei on the day of the national Pharmacopoeia press conference that stressed that after a variety of pharmacopoeia contained in a substantial increase in the current version of the Pharmacopoeia reached the basic drugs, the medicines for health coverage complete, to meet the Clinical medication needs. The 2010 edition of the Pharmacopoeia proposed varieties to accommodate moderate growth requirements, one is to consider the adjustment of the directory, the second is the focus of the work, focusing on the number of medicines received to pay attention to the inherent quality of drugs for Improving the change, which is no longer blind to pursue the number, to be more emphasis on quality.

It is understood that the new version of the Pharmacopoeia will further improve the standard system, and strengthen the concept of drug quality management. Zhang Wei stressed that the new version of the Pharmacopoeia improved and enriched the connotation of drug patterns, strengthening process control, drug terminal control for the production process and source control extension, to achieve the life of the drug system Cycle quality control pattern. The establishment of the horizontal coverage of traditional Chinese medicine, chemical drugs, biological products, pharmaceutical raw materials, pharmaceutical excipients, drug packaging materials and standard materials, technical quality control requirements, Covering the general Pharmacopoeia, general rules, general principles, test methods and guiding principles, strengthening and improving pharmaceutical research and development, production, circulation and use of links and other aspects of the requirements Common technicians and guiding principles of the standard drug system.

The next step, the national Pharmacopoeia will establish a national standard of drugs outside the mechanism. Zhang Wei proposed that the pattern of "have gone and come," drug approval number has been cancelled, long-term production, quality is not control, the irrational dosage form, stability is not high standards of "subtraction" drugs to reach the standard out , completely solve the problem of the legacy of drug patterns.

The current implementation of the Pharmacopoeia "People's Republic of China" 2015 edition is the new China since the establishment of the 10th edition of the Pharmacopoeia. The total number of drugs contained in the Chinese Pharmacopoeia reached 5608, covering the basic drugs, the varieties of medical Insurance catalogue and medicines commonly used and other clinical content