echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > Interpretation: Seven main changes in the 2015 Pharmacopoeia

    Interpretation: Seven main changes in the 2015 Pharmacopoeia

    • Last Update: 2014-10-11
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: on October 11, 2014, Zhang Wei, Secretary General of the State Pharmacopoeia Committee, said at the 2014 injection industry conference that the preparation of 2015 edition of Chinese Pharmacopoeia (hereinafter referred to as 2015 edition Pharmacopoeia) has entered a later stage In accordance with the objectives set in the outline and the principle of "progress subject to quality", all work has been carried out steadily From the overall situation, the safety, effectiveness and quality control level of the varieties collected in 2015 Pharmacopoeia have been improved, and the general goal of "chemical drugs and biological drugs reach or approach international standards, and Chinese medicine dominates international standards" has been basically achieved According to Zhang Wei, there are seven major changes in the 2015 edition of the Pharmacopoeia: first, the growth rate of collected varieties reached 27.4% There are 5800 varieties to be included in Pharmacopoeia 2015, more than 1200 more than Pharmacopoeia 2010, and 751 revised varieties Second, through the comprehensive revision of the general principles, general rules and general principles of the Pharmacopoeia, the requirements for drug quality control have been further improved on the whole, the technical provisions of the pharmacopoeia standard have been improved, and the pharmacopoeia standard has been more systematic and standardized Third, the drug standard system has been improved In particular, the number of varieties of pharmaceutical excipients increased to 260, and the relevant guidelines were added On the basis of induction, verification and specification, the common detection methods of all parts of the Chinese Pharmacopoeia were coordinated and unified Fourth, the appendix (general principles) and excipients of Pharmacopoeia 2015 are independent volumes, which constitute the main contents of the fourth part of Chinese Pharmacopoeia Fifthly, the number of drug excipients increased significantly It is planned to add 128, 260 in total, with a growth rate of 97% Sixthly, the safety control project has been greatly improved Traditional Chinese medicine: it has formulated the limit standards of sulfur dioxide residues in traditional Chinese medicine and decoction pieces, promoted the establishment and improvement of the limit standards for the detection of heavy metals and harmful elements, aflatoxins, pesticide residues and other substances, and strengthened the control of heavy metals and toxic and harmful substances in traditional Chinese medicine Chemical drugs: related substances strengthen the research of qualitative and quantitative determination methods of impurities, realize the differential control of known impurities and unknown impurities, optimize the determination methods of antibiotic polymers, set reasonable control limits, and further improve the scientificity and rationality of related substance projects as a whole Biological products: increase the requirements of relevant general theory, and strictly control the quality of biological products in the whole process to ensure the safety and effectiveness of products At the same time, add the "general technical requirements for quality control of raw and auxiliary materials used in the production of biological products", strengthen the source control, and minimize the safety risks Seventh, further strengthen the effectiveness control Chinese herbal medicine strengthens the identification of specific properties and the setting of content determination items Chemical drugs appropriately increase the index of controlling the effectiveness of preparations, and establish scientific and reasonable inspection methods Biological products further improve the standardization of potency test methods, strengthen the research and application of in vitro method instead of in vivo method, and ensure the accuracy and operability of potency test methods The formation mechanism of drug standards to be explored Pharmacopoeia revision is the key foundation to improve the overall level of drug field Zhang Wei pointed out that the current Pharmacopoeia still needs to face some practical problems First, the overall level of drug standards is low At present, there are more than 13000 standards issued by the Ministry or the Bureau, accounting for 76% (the standards issued by the Bureau, the standards issued by the Ministry and the Pharmacopoeia are all national standards) There are some problems in these standards, such as the backward detection method, the weak specificity, the inaccuracy in the determination of the effective components, and the unreal reaction of the impurity content Secondly, the elimination mechanism of drug standards is not perfect There is an urgent need to establish a scientific and standardized elimination mechanism for drugs and their standards Third, the ability and internal motivation of enterprises to improve drug standards are insufficient Fourth, China has not established a unified, dynamic and efficient information platform for drug standards, so it is difficult to accurately count the number of drug standards in China, resulting in the overall bottom of the standard is countless; it is difficult to compare and analyze the existing drug standards, resulting in the overall level of the standard is unknown; it is difficult to check the latest standards, resulting in the implementation of error prone Finally, there is no basis for information sharing due to the lack of a unified electronic data dictionary for drug standards Zhang Wei believes that to solve these problems, first, we need to continue to promote the implementation of the national action plan for improving drug standards, focusing on the improvement of standards for high-risk varieties such as those listed in the national basic drugs and medical insurance catalogue, injections, vaccines, and products such as traditional Chinese medicine and ethnic medicine; Second, we should speed up the process of the reform of the formation mechanism of national drug standards, and form a new pattern of "in and out, increase and decrease"; Thirdly, we should speed up the establishment of the national drug standard information platform and incorporate it into the construction plan of the State Administration of drugs, standardize the national drug standard information, and realize the automation and networking of drug standard inquiry, retrieval, release, analysis, research and maintenance; Four is to speed up the promotion, implementation and supervision of the Chinese Pharmacopoeia, strengthen the supervision of the implementation of the Chinese Pharmacopoeia, and ensure the implementation of the provisions of the Chinese Pharmacopoeia; Fifth, we need to accelerate the process of promoting the internationalization strategy of China's drug standards, face both domestic and international markets, and make China Pharmacopoeia and China's drug standards become influential and competitive international standards, and truly rank among the advanced international standards.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.