Consistency evaluation is the key to improve the quality of base charge

Source: medical economic news 2016-02-26 At the executive meeting of the State Council held this month, it was planned to promote the innovation and upgrading of the pharmaceutical industry and determine measures to further promote the development of traditional Chinese medicine It was mentioned that the safety evaluation and product traceability system should be improved, the quality supervision of the whole process should be strengthened, the international advanced level should be benchmarked, and the actions to improve the standards of drugs and medical devices, especially the quality of essential drugs, should be implemented At the same time, we should increase the input and policy support of traditional Chinese medicine, increase the number of varieties of Chinese patent medicine in the national basic medicine catalogue, and better play the role of "basic protection" In the view of the industry, the current state attaches great importance to the quality of base drugs, especially the promotion of the quality and efficacy consistency evaluation of generic drugs, the quality of base drugs will be improved At the bidding level of basic drugs, if the varieties that pass the consistency evaluation can win the bid, the bidding varieties of basic drugs may be reshuffled In addition, it is also an important policy direction to increase the number of varieties of Chinese patent medicines when the national base drug catalogue enters a new round of adjustment period According to Dr Chen Hao, a researcher at the Research Center for drug policy and management of Huazhong University of science and technology, consistency evaluation or bid shuffling of basic drugs, document 3 was issued at the beginning of this year, which will integrate urban and rural residents' medical insurance Accordingly, basic drugs play an important role in the integrated medical insurance catalogue of urban and rural residents The establishment of basic drug system is one of the major achievements of medical reform, and the basic drug system is also expanding In his opinion, under the circumstances of "three medical linkage" reform and the limitation of drug use catalogue, proportion and amount in public hospitals, the importance of basic drugs is self-evident In the future, it will even become the main drug use component of all kinds of medical insurance, and its quality is particularly crucial To improve the quality of base drugs, it is necessary to implement some measures We can start from two aspects: strengthening the construction of supply guarantee system for production and circulation and improving scientific supervision "At the level of production and supply guarantee, we should strengthen the idea that the production enterprise is the main responsible person On the one hand, we should improve and perfect the quality standards, which should match the spirit of the new measures for the administration of drug registration and the new drug administration law; On the other hand, we should improve our ability to implement GMP and even international standard system, emphasize the overall quality management of the whole process, all factors and all elements, and fundamentally improve the quality of drugs " Chen Hao pointed out, for example, comprehensively promoting the quality and efficacy consistency evaluation of generic drugs, taking the lead in re evaluation of the whole base drug variety, etc In the view of the industry, the promotion of consistency evaluation is very important to improve the quality of base drugs The previously released opinions on the evaluation of the consistency of quality and efficacy of generic drugs (Draft for comments) requires that the consistency evaluation of the chemical generic oral solid preparations in the national essential drug catalog (2012 version) approved before October 1, 2007 should be completed before the end of 2018 In the interview, some experts said that the arrangement and promotion of the consistency evaluation of quality and efficacy of generic drugs are measures corresponding to the reform of drug registration and classification In the future, the drug classification standards, methods and results will be in line with international standards, providing preconditions and implementation rings for the following effective governance, such as the formulation of drug medical insurance payment standards, drug bidding and procurement, and the establishment and improvement of price formation mechanism Environment This is not only for basic drugs, even for all drugs and devices, but also for the limited resources and the importance of basic drugs There are uncertainties in increasing the number of Chinese patent medicines The draft also points out that enterprises are encouraged to carry out consistency evaluation If more than three varieties of the same variety have passed the consistency evaluation, the varieties that have not passed the evaluation will not be used in centralized procurement and other aspects In the view of the industry, this will have a significant impact on the bidding of basic drugs In the past, the bidding of basic drugs was more concerned about the price, and there were more cases of low-cost bidders winning the bidding "With the promotion of consistency evaluation, the winning varieties of basic drugs may face reshuffle Whether their prices rise is still difficult to make a final decision, depending on the degree of competition," a researcher from the center for health development research, who declined to be named, told this newspaper Chen Hao believes that the price of generic drugs through consistency evaluation will rise, after all, the maintenance of quality system and the realization of drug quality have rigid costs "However, No 904 document promoting drug price reform has pointed out that the formation of drug price mainly depends on market mechanism Whether the price can be really raised still depends on the market competition environment and the bargaining power of the drug itself " In this regard, some experts predict that the consistency evaluation of quality and efficacy of generic drugs will constitute a big reshuffle for the existing approval number and manufacturers in the market, a large number of enterprises and products will be restructured or withdrawn, and the situation of low-level repetitive production and vicious competition is expected to be greatly improved Accordingly, those who participate in the centralized purchase of drugs and get the approval of medical institutions and patients will be drugs with good quality, reasonable price and supply guarantee Those who get the payment support of medical insurance will also be generic drugs and base drugs that meet the above conditions In principle, the national basic drug catalogue was adjusted once every three years according to the administrative measures for national basic drug catalogue (Provisional) issued in 2009 At present, the 2012 version is implemented From the time perspective, the national basic drug catalogue has entered a new round of adjustment period However, although the national level proposed to increase the number of Chinese patent medicines in the list of basic medicines, there is a view in the industry that "is not sure": although traditional Chinese medicine is a valuable national wealth and needs to be excavated and supported, there is still a large room for improvement in the quality, safety and efficacy of traditional Chinese medicine varieties, and its reasonable use is unsatisfactory In the medical reform measures, such as the proportion of drugs, the double limit of purchase amount, the reform of medical insurance payment method, the limitation of auxiliary treatment drugs and even the limitation of the quantity of Zhongcheng drugs, all pose great challenges to the use of Chinese patent medicine "Under the existing national basic medicine catalogue and provincial supplementary catalogue, the number of varieties of traditional Chinese medicine is basically sufficient." Chen Hao said that the direction of catalog adjustment should be to integrate the situation of national base drugs and provincial supplements, and correspondingly reduce the scale of the total catalog to a reasonable level In the future, the relevant departments should straighten out the relationship between the basic medicine catalogue, the integrated urban and rural medical insurance catalogue and the employee medical insurance catalogue, and pay attention to the drug connection of hierarchical diagnosis and treatment.