How to solve the dilemma of medical standardization? Strengthening the main body of enterprises is the key

Drug standards are regarded as the "protective wall" to protect the safety and effectiveness of public drug use, but now the "wall" has been criticized repeatedly - the quality of drugs is not up to standard, and even serious accidents are frequently reported Especially in the previous period, the news that the traditional Chinese medicine injections, which repeatedly caused adverse reactions, were selected into the list of base drugs, raised a wave of controversy again On the one hand, China has been increasing investment in biomedical industry in recent years; on the other hand, this national strategic emerging industry has always been difficult to solve the dilemma of standardization To this end, sun Zhongshi, an expert of the national rational drug use monitoring system of the national health and Family Planning Commission, is blunt: the overall level of drug standards in China is still low, especially in the field of traditional Chinese medicine According to the information disclosed by the head of relevant national authorities, China is promoting the strategy of drug standardization Not long ago, Zhang Wei, Secretary General of the State Pharmacopoeia Commission, told the author his thoughts on the implementation of China's drug standardization strategy The overall level is low From the definition, drug standard is the basic technical requirements for a certain target compound or prescription process, and is one of the important basis for daily inspection or evaluation of drug quality compliance At the same time, the perfection of drug standard is the final embodiment of comprehensive strength, such as technological level, analytical technology and personnel quality "The development level of drug standards indirectly represents the development level of a country's drug industry." Zhang Wei said But now, China's drug standards are plagued by many problems According to the introduction, limited by historical conditions and the development stage of China's pharmaceutical industry, the level of China's pharmaceutical standards is relatively low Generally, there are problems such as backward detection methods, weak specificity, inability to accurately determine the effective ingredients, inability to truly reflect the content of impurities and so on The aging problem of standards is also more prominent Sun said the above problems are particularly serious in the field of traditional Chinese medicine "Up to now, the management of traditional Chinese medicine has not formed a national, unified, scientific and standardized system." For example, the quality of traditional Chinese medicine preparation is greatly affected by raw materials, but there is no unified national standard for raw materials "There should be a standard for the content of effective ingredients The effective ingredients of raw materials produced in different regions will vary many times." Behind the problem of standard aging, there is also a problem of imperfect elimination mechanism Zhang Wei pointed out that at present, the implementation of drug standards is lack of evaluation means, lack of supervision, and the drug standards are "only alive and not dead" It is urgent to establish a scientific and standardized drug standard elimination mechanism According to sun Zhongshi's analysis, the main reason why the "aging" drug standard is difficult to be eliminated is that China's ability to collect data on adverse drug reactions is insufficient "The FDA can say how many cases of adverse drug reactions there are, and there is a basis for" shooting "the drug, but we lack a sound reporting mechanism, and it is difficult to grasp detailed data." A drug company official, who declined to be named, speculated that the interests of backward drug companies were also involved "It takes a lot of time and money for pharmaceutical companies to make a product Some are even the first such drugs in China Even if they are gradually backward, they are not easy to be eliminated from the Pharmacopoeia." For pharmaceutical enterprises, the lag of information construction still has the problem of insufficient ability to improve drug standards and internal motivation Zhang Wei said that for a long time, the leading role in the improvement of drug standards in China has been the government departments, while enterprises are unwilling to take the initiative to participate in it, only passively implement it "The enterprise lacks the financial investment and technical ability to improve the standard, and only satisfies that the drugs produced meet the standard In addition, the government lacks policy support and interest protection measures to improve drug standards Enterprises can not only not benefit from the initiative to improve standards, but also may increase the cost of production, inspection and quality control " Zhang Wei analyzed He believes that in the long run, enterprises will inevitably become spectators from participants in the improvement of standards, from active improvement of individual registration standards to passive implementation of common national standards A Deputy quality director of a domestic biopharmaceutical enterprise said that the enterprise does not have too many opportunities to participate in the research projects or topics related to drug standards, and there are limited representatives from the enterprise among the professional members of the Pharmacopoeia Committee At the same time, the enterprise will increase the time and capital cost by improving the standards At present, there is no corresponding incentive mechanism, and the market does not reflect the feedback of high quality and good price Therefore, the The power of enterprises to improve standards is insufficient In addition, there is still a lag in the construction of drug standard information in China, and a unified, dynamic and efficient drug standard information platform has not been established The consequences are: it is difficult to count the number of drug standards in China, and the overall bottom of the standards is countless; it is difficult to compare and analyze the existing drug standards, and the overall level of the standards is unknown; it is difficult to query the latest standards, and the implementation is prone to errors; because there is no unified drug standard data dictionary, there is no basis for information sharing For the above problems, the deputy director of quality, who did not want to be named, has a deep understanding: FDA has a relatively complete database of drug registration on the market However, due to the relatively backward level of information in this field in China, pharmaceutical companies sometimes have difficulty in finding the relevant information about the establishment of necessary drug registration standards "I hope that the state can establish relevant standard databases, even for paid queries, which will be very helpful to enterprises." At present, strengthening the main body of enterprises, the problem of drug standards is like an invisible hand, which has caught the throat of China's biomedical industry Most developed countries have raised the drug standardization to a strategic level, striving to make their own standards become international standards "Third class enterprises sell coolie, second class enterprises sell products, first-class enterprises sell patents, and top-class enterprises sell standards," Zhang said This sentence profoundly reveals the international market competition game of "the standard winner wins the world" According to him, China is actively promoting the strategy of drug standardization, the core of which is to improve the adaptability and competitiveness of drug standards At the same time of government guidance, we should first make the standards meet the needs of the market and enterprises, and make enterprises become the main body of standardization activities Zhang Wei suggested that, according to the enterprise's own positioning, the standardization activities of the enterprise should be actively carried out On the basis of adopting and absorbing international standards and national standards, the standards with their own technical characteristics and competitiveness should be formed Enterprises should also actively engage in the standard formulation and revision work of their own industry, and strive to become the leader In this regard, a number of business leaders interviewed agreed and said that at present, we can see some positive changes, and the government departments will ask for more ideas from enterprises than before At the system level, Zhang Wei believes that the current situation of multi standard management should be changed to form a drug standard management system with clear responsibilities, reasonable division of labor, smooth relations and close cooperation We will improve the starting mechanism, incentive mechanism, evaluation mechanism and elimination mechanism for the formulation and revision of drug standards In addition, he also suggested that we should speed up the construction of drug standard information, establish a drug standard information platform, realize the network and automation of drug standard publication, query and retrieval, analysis and review, and even formulation and revision, enhance the accuracy and timeliness of drug standard information, and improve the quality and efficiency of drug standard management.