2020 Edition of Chinese Pharmacopoeia to Improve Testing Programs for Traditional Chinese Medicine Standards


Published time:

12 Jul,2018

  The National Pharmacopoeia Commission recently held a mini-conference on the preparation of the 2020 edition of the Chinese Pharmacopoeia. At the meeting, Zhang Wei, Secretary General of the National Pharmacopoeia Commission, said that the 2020 edition of the Pharmacopoeia will further consolidate and expand the achievements of the standardization of traditional Chinese medicine, improve the testing items of traditional Chinese medicine standards, comprehensively improve the safety and efficacy of traditional Chinese medicines, and continue to lead the development of international standards.
  It is understood that the Pharmacopoeia has an important guiding role in China's drug research and development, registration and approval, especially for the quality control of China's medicines and the development of standards has a very important role in guiding and standardizing. The compilation of the Pharmacopoeia is based on a full study of the safety, efficacy, quality and standards of listed medicines, and the timely identification of problems such as missing or imperfect standards in the listing, to make up for the shortcomings and to further improve the quality control of listed medicines.
  Zhang Wei introduced that the Pharmacopoeia is now getting more and more attention from countries all over the world, and has been listed by the World Health Organization as one of the main references for the development of the International Pharmacopoeia. The Pharmacopoeia plays an important role in reflecting the current situation of China's pharmaceutical development, spreading the culture of Chinese medicine, demonstrating the quality control level of China's medicines and enhancing the international influence of the Chinese Pharmacopoeia.
  Zhang Wei admitted in an interview with the reporter of Economic Daily - China Economic Net that "the formulation and revision of drug quality standards is a complex process, which should be compatible with the development of scientific and technological testing level, and also take into account the level of development of the national pharmaceutical industry, and establish scientific, comprehensive, testable and enforceable standards, which is difficult and challenging for the relatively complex composition of traditional Chinese medicine. The difficulties and challenges are self-evident for Chinese medicines with relatively complex components.
  For the Chinese herbal medicines and drinking tablets, such as substandard, adulteration and other unspoken rules of the industry, as well as some of the pesticide residues, heavy metals and harmful elements of the herbs exceeded the standard and other issues. Zhang Wei believes that "these problems seriously affect the quality and safety of Chinese herbal medicines, jeopardize public health, and impede the healthy development of the Chinese herbal medicine industry and the cause of Chinese medicine."
  Zhang Wei said, the State Food and Drug Administration Bi Jingquan, director of the State Food and Drug Administration, proposed to focus on cracking the adulteration and counterfeiting "unspoken rules". "Pharmacopoeia is a technical regulation made by the state to ensure the quality of medicines and the quality indicators of medicines. Pharmacopoeia standard is a tool or basis for testing and evaluating the evaluation of drug quality, so that the standard is the regulatory enforcement of the standard, but also to ensure that drugs are safe and effective basis. Doing a good job in drug standards and formulating scientifically rigorous, applicable and manageable standards is of great significance for effective regulation and precise supervision."
  "We will ensure the quality of Chinese herbal medicines and drinking tablets and ensure the safety of public medicines by establishing the most rigorous standards and continuously improving the traceability system, strengthening the supervision of the whole process and the whole industrial chain, etc." Zhang Wei said.
  According to the Economic Daily News - China Economic Net reporter, the 2020 version of the Pharmacopoeia will further improve the testing program of Chinese medicine standards, and comprehensively improve the safety and effectiveness of Chinese medicine. It focuses on strengthening the research and development of quality standards for Chinese medicine tablets, and establishing and improving the quality standards for Chinese medicine tablets: it will continue to research and establish efficient and sensitive analytical methods and detection technologies for exogenous harmful substances such as heavy metals and harmful elements, pesticide residues and fungal toxins, as well as their limitation standards, and comprehensively use them for the quality control of Chinese herbal medicines and tablets to enhance the safety control level of traditional Chinese medicines; and establish and improve the determination of the active ingredients, multiple Establish and improve the determination of active ingredients, multi-ingredient determination and characterization/fingerprinting detection technology, and explore and study the evaluation method of biological activity, so as to comprehensively improve the level of effectiveness control of traditional Chinese medicines.

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