Let generic drugs "take root" and introduce policies to promote consistency evaluation

[China Pharmaceutical network industry trends] generic drugs play an important role in whether patients can use drugs According to the industry, whether it is chemical drugs, innovative drugs or biological drugs, generic drugs will still occupy one of the leading positions in the whole market "Because the expensive original research drugs are hard for patients to bear, with the introduction of international innovative drugs and original research drugs by national policies, the pressure of medical insurance will become more and more serious, so the role of generic drugs is crucial." Generic drugs play an important role, so improving the quality of generic drugs has attracted the attention of the state Pharmaceutical companies need to constantly improve the quality of generic drugs Among them, the implementation of generic drug consistency evaluation will help to speed up the survival of the fittest in China's pharmaceutical industry and improve the overall quality of drugs Consistency evaluation is one of the drug quality requirements in the 12th Five Year Plan for national drug safety, that is, the country requires that the quality and efficacy of generic drugs should be consistent with that of the original drugs Specifically, it is required that the impurity spectrum is consistent, the stability is consistent, and the dissolution rule in vitro and in vivo is consistent To evaluate the consistency of quality and efficacy of generic drugs is to encourage the substitution of original drugs I learned that recently, many policies have been issued to promote the consistency evaluation of generic drugs For example, recently, the Department of science and technology, the Department of finance, the economic and Information Commission and the food and Drug Administration of Fujian Province jointly issued the measures for the implementation of the fund subsidy for the consistency evaluation of quality and efficacy of generic drugs in Fujian Province, which clearly defined that for the varieties of drug manufacturers in Fujian Province that have completed the consistency evaluation and approved the listing, a one-time subsidy will be given according to the proportion of 20% of the evaluation cost and no more than 1 million yuan In order to promote the consistency evaluation of quality and efficacy of generic drugs, the implementation opinions put forward to encourage competent drug research institutions and drug inspection institutions in Fujian Province to actively participate in the research of prescription technology and quality, and to establish a green channel for consistency evaluation, and to do a good job in the rapid approval and customs clearance of one-time imported drugs for research and development of reference drugs In order to encourage enterprises to carry out consistency evaluation, the Implementation Opinions also put forward that all drugs that have passed the consistency evaluation by drug manufacturers in Fujian Province can be included in the medical insurance catalogue of Fujian Province In the joint procurement of drugs, they can enjoy the same quality level treatment as the expired original research drugs, and encourage medical institutions to purchase for clinical selection first In addition to Fujian Province, Qingdao, Shandong Province has also issued several policies and measures to promote and encourage the consistency evaluation of quality and efficacy of generic drugs, so as to promote more enterprises to improve the quality of generic drugs by actively carrying out the consistency evaluation of quality and efficacy of generic drugs The policy provides policy and financial support for the consistency evaluation of generic drugs produced and taxed in Qingdao   In terms of financial support, the policy grants 3 million yuan to each variety that has passed the consistency evaluation of national generic drugs after being put into production; grants the same amount to the off-site drugs that have passed the consistency evaluation and have been transferred to Qingdao city and produced according to the production quality management standards; grants the human bioequivalence test (be) and exemptions in the consistency evaluation of generic drugs, And for the varieties that pass the consistency evaluation, RMB 1 million will be awarded for each variety At the same time, Qingdao will give support to the varieties that pass the consistency evaluation in drug bidding procurement and clinical medication Under the same conditions, the municipal and grass-roots medical institutions will give priority to using the varieties that pass the consistency evaluation in Qingdao The promotion of the consistency evaluation of generic drugs is of great significance to the high quality of generic drugs To evaluate the consistency of quality and efficacy of generic drugs is to encourage the substitution of original drugs It is reported that more than 10 provinces and cities, including Shanghai, Jiangsu, Shanxi, Shaanxi, Zhejiang, etc., have issued specific procurement policies for varieties passing the consistency evaluation Some insiders pointed out that with the normalization and institutionalization of generic drug consistency evaluation, the enthusiasm of domestic pharmaceutical enterprises will be further released This will play a positive role in the R & D and production of generic drugs, as well as the use of cheap and high-quality drugs for patients Experts pointed out that by promoting the consistency evaluation of generic drugs, gradually expanding the market scale of generic drugs, creating a good development environment for them, making generic drugs more fully compete with innovative drugs, which can drive the price of innovative drugs back to the level of generic drugs, is a feasible way to reduce the drug price The author learned that on July 26, a new batch of approval list of conformity evaluation of quality and efficacy of generic drugs published by the State Food and drug administration showed that a total of 8 varieties (16 product specifications) passed This also means that in the five batches of the list that have been released, a total of 65 product specifications have been officially adopted The purpose of imitation is to replace The consistency evaluation is very important for the generic drugs to replace the original drugs, but it is not easy for enterprises to pass the consistency evaluation The industry said that in order to produce drugs that are comparable to the technology and quality of the original research drugs, pharmaceutical enterprises need more capital and technical strength In this regard, experts said that to make generic drugs "take root", we need to rely on "multi-faceted efforts".