Zhejiang consistent evaluation benefits cash! Top three: 3 million through variety Award
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Last Update: 2018-03-27
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Source: Internet
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Author: User
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Source: medical economic daily March 27, 2018 Medical network, March 27, March 26, Zhejiang Province issued the management measures for the award and supplement funds of generic drug consistency evaluation, which clearly defined that the top three pharmaceutical manufacturers in the country who passed the generic drug consistency evaluation will be given a one-time award and supplement of 3 million yuan for each variety, and made clear provisions on the procedures for the allocation of award and supplement funds, the use of award and supplement funds, and the supervision of award and supplement funds So far, in June 2017, the implementation opinions on accelerating the evaluation of the quality and efficacy of generic drugs and the pilot work of the drug listing license holder system issued by the general office of the people's Government of Zhejiang Province, the incentive policies for awards and subsidies were implemented at the operational level According to the query of insight database, up to now, there are 107 acceptance numbers of consistency evaluation, including amlodipine of Zhejiang Jingxin Pharmaceutical Co., Ltd and atorvastatin calcium tablets of Zhejiang xindonggang Pharmaceutical Co., Ltd According to the data statistics of Zhejiang food and drug administration, up to now, Zhejiang Province has completed 29 generic drug conformity evaluation reports to CFDA, 14 of which have been announced by CFDA to pass the generic drug conformity evaluation, and another 2 have been announced as reference preparations The number of varieties declared and passed the consistency evaluation of generic drugs is leading in the country It is also today that Shaanxi provincial centralized procurement network of pharmaceutical equipment has put up a notice on carrying out the sunshine procurement of generic drugs through the consistency evaluation of quality and efficacy, including Zhejiang Huahai Pharmaceutical Co., Ltd lisinopril tablets 10mg; Zhejiang Jingxin Pharmaceutical Co., Ltd ruishuvastatin calcium tablets 10mg and 5mg and other 18 regulations have been applied and approved in Shaanxi procurement platform, Zhejiang Province 6 undeclared varieties, such as 5mg lisinopril tablets of Jianghua Pharmaceutical Co., Ltd., need to be declared on the platform The notice also requires that supplementary applications be made for varieties deemed to have passed the conformity assessment There are three types of consistency evaluation subsidies in different regions Except for Zhejiang, Jiangxi, Anhui and other provinces, as well as Harbin, Haikou and other cities have proposed to provide certain project financial support and subsidies for products passing the consistency evaluation In addition, some places have issued the draft for comments, which is intended to provide a certain amount of project fund support for each drug manufacturer and each product through the consistency evaluation Such as Guangzhou biomedicine The five-year action plan for industrial development (2017-2021) (Draft for comments) proposed to provide financial support of 2-3 million yuan for each category of preparations in the list of essential drugs in Guangzhou that passed the conformity assessment of generic drugs according to national regulations and other chemical preparations that took the lead in the top three countries that passed the conformity assessment of generic drugs According to the analysis of Guojun pharmaceutical, the types of subsidies in different regions are as follows: 1 Cash subsidies: 500000-600000, the highest is Bozhou, Anhui Province, with a subsidy of 6 million yuan Most of them are subsidized at the provincial and municipal levels 2 Sales subsidy: different amount of subsidy will be given for different sales, for example, when the sales in Fuyang reaches 10 million yuan, a subsidy of 300000 yuan will be given 3 Coordinate be resources: coordinate the clinical bases (Beijing, Bengbu), and grant subsidies (Chongqing) according to each approval document to the municipal institutions undertaking the bioequivalence test of drugs in the city after the drugs pass the consistency evaluation The bidding dividend of over consistency evaluation varieties under the background of the overall face of bidding and price reduction of generic drugs, the consistency evaluation of generic drugs brings the opportunity for excellent generic companies to "overtake in the corner" and improve market share In fact, in addition to the reward and subsidy funds directly given by all regions, from the perspective of relevant policies, the varieties preferentially passing the consistency evaluation have obvious alternative space for the original research monopolized varieties, and will also enjoy preferential policies such as preferential procurement, medical insurance, etc For example, Inner Mongolia Autonomous Region and other regions have made it clear that "all the drugs that pass the consistency evaluation are in the same bidding group with the original research drugs in the bidding procurement, and the same kind of drugs pass the consistency evaluation If there are more than three, the products that fail to pass the consistency evaluation will not be used in the centralized purchase of drugs; if there are less than three, the products that have passed the consistency evaluation will be preferentially purchased and used " Shaanxi Province issued a notice to clarify that in the centralized procurement of drugs in the province, the varieties passing the consistency evaluation should be treated equally with the original drugs For the varieties passing the consistency evaluation, all purchasing consortiums and medical institutions at all levels shall include them in the list of interchangeable drugs with the original research drugs, and give priority to purchase and use When negotiating the purchase price with quantity, it should be at the same bargaining level with the original research drug, and gradually reduce the price gap with the original research drug It has been reported that Tianjin, Shanxi, Inner Mongolia, Liaoning, Jilin, Shandong, Heilongjiang and other provinces have given preferential treatment in the bidding procurement, and drugs through the quality consistency evaluation of generic drugs will be included in the first bidding group The average evaluation time is only 70 working days At present, a breakthrough has been made in the conformity evaluation of generic drugs The reporter noted that the latest 2017 annual drug review report released on March 22 showed that the review of the first 52 consistency assessment applications had been completed, including 13 varieties (17 specifications) of drugs passing the consistency assessment There are 6028 registered reference preparations, including 3141 289 varieties and 695 enterprises As for the filing and exemption research of bioequivalence Research (be), by the end of 2017, there were 309 filing of be for consistency evaluation, including 182 289 varieties, 124 enterprises in total, 73 varieties; 127 non 289 varieties, 84 enterprises in total, 77 varieties Based on scientific research, 82 varieties (2 batches) of be in vivo can be exempted, and the first 49 varieties recommended can be exempted or simplified It is also worth mentioning that the time for review and approval has decreased significantly Among them, the average time for review and approval of generic drug conformity assessment application is about 70 working days, only half of the statutory time limit As the time limit for consistency evaluation is the end of 2018, some industry analysts suggest that for some small and medium-sized enterprises, it is wise to give up the relevant varieties, save time, and use the funds for the varieties that have made rapid progress and are most likely to compete for the market.
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