At present, there are many shortcomings in the field of drug standards in China. The new edition of the Pharmacopoeia of the People's Republic of China no longer pursues quantity in the collection of drug products, but pays more attention to quality. In the future, the collection of Pharmacopoeia varieties will be intrinsic, inexhaustible, and promote the healthy development of the entire industry.
Not long ago, the National Pharmacopoeia Committee held a press conference to announce that, based on the overall status of national drug standards, the 11th edition of the Pharmacopoeia of the People's Republic of China, which will be released in 2020, is expected to contain about 6,400 varieties of drugs. Among them, about 800 varieties of Chinese medicines, chemical medicines, and biological products were added.
"The Pharmacopoeia is the technical regulation made by the state to ensure the quality of medicines and the quality indicators of medicines. Pharmacopoeia standards are the basis for testing and evaluating the quality of medicines, and also the basis for ensuring the safety and effectiveness of medicines." Zhang Wei, secretary general of the State Pharmacopoeia Commission, said that The 2015 edition of the Pharmacopoeia of the People's Republic of China was the 10th edition of the Pharmacopoeia since the founding of the People's Republic of China. The total number of drugs in this edition of the Pharmacopoeia reached 5,608, covering the basic drugs, medical insurance catalogues and other content, which can basically meet the needs of clinical medication.
Zhang Wei said that the 2020 edition of the Pharmacopoeia put forward the requirement for moderate growth in variety collection. First, it is necessary to consider the adjustment of the catalogue. Second, the focus of the work shifts from focusing on the quantity of medicines loaded to focusing on the improvement of the intrinsic quality of medicines. Pursue quantity, but emphasize quality more. On the one hand, high-quality products will be used as a benchmark to formulate high-level drug standards; on the other hand, through research, timely identification of missing or imperfect standards in listed drugs, fill in shortcomings, and further improve the listing of drugs Quality control level to improve the safety and effectiveness of drugs.
In concrete terms, the current shortcomings of drug standards are mainly due to the lack of standards, backward standards, no use of standards, and inadequate implementation of standards in some specific varieties or categories. The reason is that the standard of drug listing is not high, and the original research product is lacking as a reference preparation. For example, in the safety control of Chinese herbal medicines and decoction pieces, although there are detection methods for pesticide residues, heavy metals and harmful elements, the detection limit of specific varieties cannot be scientifically set due to the lack of accumulation and analysis of big data.
"The revision of drug quality standards is a complicated process, especially for traditional Chinese medicines with relatively complex ingredients. The difficulties and challenges are self-evident." Zhang Wei said that in recent years, with industrialization and marketization Expansion and upgrading, China's Chinese herbal medicine industry has developed rapidly, but the Chinese herbal medicines and decoction pieces market has been submerged, doped and fake industries and other "hidden rules" and some pesticide residues, heavy metals and harmful elements exceeded the standard and seriously affected the quality of Chinese herbal medicines. Safety has hindered the healthy development of the Chinese herbal medicine industry and the Chinese medicine industry.
In order to ensure the safety of public medicine and to better serve the Chinese medicine industry, the 2020 Pharmacopoeia will systematically sort out 618 kinds of medicinal materials (823 pieces of decoction pieces) contained in the 2015 edition of the Pharmacopoeia, and continue to study and establish heavy metals and harmful elements and pesticides. High-efficiency sensitive analysis methods and detection techniques for exogenous harmful substances such as residues and mycotoxins and their limit standards, further improve the testing items of Chinese medicine standards, and focus on strengthening the research and formulation of quality standards for Chinese medicine decoction pieces.
In addition, the new Pharmacopoeia will further improve the standard system and strengthen the concept of full-process management of drug quality. In this regard, Zhang Wei also revealed that the new version of the Pharmacopoeia will improve and enrich the connotation of drug standards, strengthen process control, and extend the control of pharmaceutical terminals to the production process and source control to achieve a quality control standard system for the drug life cycle.
For example, the new edition of the Pharmacopoeia will establish technical requirements for quality control of Chinese herbal medicines, chemical medicines, biological products, APIs, pharmaceutical excipients, pharmaceutical packaging materials and reference materials, covering the Pharmacopoeia, General Principles of Preparation, General Principles, and General Rules for Inspection Methods. The guiding principles, while gradually strengthening and improving the drug standard system involving the general technical requirements and guiding principles of drug development, production, circulation and use.
The National Pharmacopoeia Commission will also establish a phase-out mechanism for national drug standards. "The collection of Pharmacopoeia varieties will adhere to the principle of optimizing increments and reducing stocks, and the quantity will increase moderately, and the quality will be lacking." Zhang Wei said that it is necessary to eliminate some backward products and backward standards by establishing a sound selection principle for the entry and exit of Pharmacopoeia varieties. That is to say, the standard should be “have in and out”, and “subtract” the drug standard that has cancelled the drug approval number, long-term non-production, uncontrollable quality, unreasonable dosage form, and low stability, thus achieving the elimination of the standard. , thoroughly solve the problems left over from the history of drug standards.