Just released by the General Administration: the first batch of drugs that pass the consistency evaluation will be given the policy support of medical insurance payment, priority procurement and priority selection. Is the spring of generic drugs coming?

Source: 4:0, 2018-1-5 state food and Drug Administration issued another document today affirming the importance of the first batch of drugs passing the consistency evaluation, and emphasized in the document: According to the policy of encouragement and support for the consistency evaluation of drugs in China, the follow-up General Administration will coordinate with the national health and Family Planning Commission and other relevant departments to implement the medical insurance payment, priority procurement, priority selection and other issues related to these varieties At the same time, the General Administration will also strengthen post market supervision on the varieties passing the consistency evaluation, increase various inspections, especially flight inspections, promote strict and continuous compliance of drug manufacturing enterprises, promote continuous improvement of enterprise management level, and prevent the consistency evaluation from becoming "one-time" evaluation On the last working day of 2017, CDE released a big news: 11 drugs (17 regulations) passed the consistency evaluation The first batch of 17 product specifications that passed the consistency evaluation involved 7 manufacturing enterprises, of which Huahai pharmaceutical industry was particularly eye-catching in this list Six drugs (9 product specifications) of the company passed the consistency evaluation, which was a pretty good achievement This marks a solid step in the process of comprehensively improving the quality and efficacy of generic drugs in China This frequent posting also shows the determination of our country to improve the quality of drugs! Generics spring? Attached is the full text to comprehensively improve the quality and efficacy of generic drugs The first 17 product specifications passed the consistency evaluation, which attracted the attention of the pharmaceutical industry The consistency evaluation of generic drugs quality and efficacy achieved phased results The State Food and Drug Administration recently released the first 17 catalog of varieties and specifications passed the consistency evaluation of quality and efficacy of generic drugs This marks another solid step in the process of comprehensively improving the quality and efficacy of generic drugs in China The core objective of the quality and efficacy consistency evaluation of generic drugs is to comprehensively improve the quality of generic drugs and realize the clinical substitution of domestic generic drugs for the original drugs It is of great significance to carry out the consistency evaluation of quality and efficacy of generic drugs for improving the overall level of China's pharmaceutical industry, ensuring the safety and effectiveness of drugs, promoting the upgrading and structural adjustment of the pharmaceutical industry, and enhancing the international competitiveness In August 2015, the State Council issued the opinions on the reform of the review and approval system for pharmaceutical and medical devices, which takes "improving the quality of generic drugs, accelerating the quality consistency evaluation of generic drugs, and striving to complete the quality consistency evaluation of national basic drug oral preparations and reference preparations by the end of 2018" as one of the five goals of the reform of the drug review and approval system In February 2016, the State Council issued the opinions on the evaluation of quality and efficacy consistency of generic drugs, marking the comprehensive opening of the consistency evaluation The opinion once again clarifies the evaluation object and time limit, and requires that the generic drugs approved for listing before the implementation of the new registration and classification of chemical drugs should be evaluated for consistency if they are not approved in accordance with the principle of consistency with the quality and efficacy of the original drugs For the chemical generic oral solid preparations approved for marketing before October 1, 2007 in the national essential drugs catalogue (2012 Edition), the conformity evaluation shall be completed by the end of 2018 In October 2017, the general office of the CPC Central Committee and the general office of the State Council jointly issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices, reiterating once again the need to accelerate the promotion of the quality and efficacy consistency evaluation of generic drugs In recent years, the General Administration of China has stepped up the reform of drug review and approval system, gradually solved the problems such as shortage of resources of clinical trial institutions of bioequivalence test (be), difficulty in obtaining reference preparations, made a solid job in the selection of reference preparations, exempted the research of be varieties in vivo, strengthened the review, verification, inspection and other work, and accelerated the promotion of consistency evaluation As of January 2, 2018, there are 309 records of be for consistency evaluation, 182 of which belong to the list of basic drugs, 73 varieties of 124 enterprises, 127 out of the list, 77 varieties of 84 enterprises; 6028 records of reference preparations, 3141 of which belong to the list of basic drugs; 695 enterprises for record Among the 13 varieties (17 specifications) that have passed the consistency evaluation, there are 4 varieties (4 specifications) in 289 specifications, and 9 varieties (13 specifications) in non 289 specifications The product specifications, enterprise research reports, bioequivalence test data and evaluation information of the above varieties can be inquired through the information disclosure column of the drug audit center of the General Administration of China According to the policy of encouragement and support for the consistency evaluation of drugs in China, the follow-up General Administration will coordinate with the national health and Family Planning Commission and other relevant departments to implement the medical insurance payment, priority procurement, priority selection and other issues related to these varieties At the same time, the General Administration will also strengthen post market supervision on the varieties passing the consistency evaluation, increase various inspections, especially flight inspections, promote strict and continuous compliance of drug manufacturing enterprises, promote continuous improvement of enterprise management level, and prevent the consistency evaluation from becoming "one-time" evaluation.