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    Home > Active Ingredient News > Drugs Articles > Three varieties in the generic conformity assessment 289 catalogue have been abandoned

    Three varieties in the generic conformity assessment 289 catalogue have been abandoned

    • Last Update: 2017-08-07
    • Source: Internet
    • Author: User
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    Source: medical economic news 2017-08-07 Medical network, Aug 7, recently, the reporter learned from the "2017 high level seminar on the consistency evaluation of quality and efficacy of generic drugs", among the 289 varieties that have been evaluated nationwide, 286 varieties have been selected by enterprises not to give up evaluation, 274 varieties have been evaluated and 12 varieties have not been evaluated Among them, medroxyprogesterone acetate capsule, diclofenac sodium sustained-release capsule III and clindamycin hydrochloride tablets were all temporarily abandoned Relevant experts of the leading group for the reform of the evaluation and approval system of pharmaceutical and medical devices said that with the continuous promotion of the consistency evaluation of generic drugs, enterprises are more and more determined to give up some varieties, the wait-and-see mood of enterprises for the consistency evaluation is significantly reduced, and the attitude on whether to evaluate the famous varieties is more and more clear According to the statistical data of each stage of the consistency evaluation, the reference preparation has been put on record in an all-round way, the pharmaceutical research has been carried out extensively, and 126 be trials have been put on record successfully In addition, for the abandoned varieties, Jiangsu Province has explored some new paths, which can be used for reference by other provinces and cities According to the relevant person in charge of Jiangsu food and drug administration, there are 445 drug approval numbers in Jiangsu Province for consistency evaluation, and 247 varieties have been abandoned In order to solve these abandoned varieties, Jiangsu Province is the first to issue a public announcement to the society on the platform of the Provincial Bureau, using the drug listing permit holder system to conduct public bidding On August 17, 2016, the State Food and Drug Administration issued a document announcing the approval number of generic drugs to be completed before the end of 2018 By the end of May 2017, 31 provincial bureaus had reported the information of all varieties in 289 catalogue of conformity assessment varieties, involving 16287 approval numbers and 1649 production enterprises In terms of the whole country, except that there are no 289 varieties in Tibet, other provinces have carried out the consistency evaluation 14 provinces including Henan, Shanghai, Shanxi, Shandong and Jiangsu carried out the evaluation with more than 100 approval numbers, and the evaluated varieties accounted for more than 50% of the total In Inner Mongolia, Gansu, Xinjiang and other three provinces, the number of approval documents for evaluation is only a single digit, and the proportion of evaluated varieties to be evaluated is only less than 10%, and the overall evaluation progress is obviously lagging behind At the meeting, relevant experts pointed out that although the overall progress of generic drug conformity assessment was smooth, there was still imbalance in progress In particular, because different enterprises have different understanding of the consistency evaluation work, the enthusiasm of carrying out the evaluation is different, and the progress is obviously different Some large-scale pharmaceutical enterprises still have serious negative waiting situation The number of approval documents to be evaluated is more than 30, but the number of evaluations carried out is small, the proportion is less than 10%, and the progress is obviously backward According to incomplete statistics, among the 1694 enterprises, there are 758 enterprises that have carried out consistency evaluation of varieties, accounting for 44.7%; 936 enterprises that have not yet carried out consistency evaluation of varieties, accounting for 55.3%; 15 enterprises such as Shanghai Xinyi Tianping Pharmaceutical Co., Ltd., Kaifeng Pharmaceutical Co., Ltd and Tianfang Pharmaceutical Co., Ltd have carried out more than 30 approval numbers of evaluation Zhejiang Jingxin Pharmaceutical Co., Ltd and Jiangsu Yangzijiang Pharmaceutical Co., Ltd have completed the declaration of varieties The adjustment goal is expected to achieve and promote the quality and efficacy consistency evaluation of generic drugs, which is the key work of the State Administration in 2017 As of the press release, the State Food and drug administration has officially released eight batches of generic drug conformity evaluation reference preparations catalogue, with a total of 610 reference preparations of product specifications, 224 of which belong to the 289 catalogue, and 386 of which are beyond the 289 catalogue At the same time, in order to standardize and guide all aspects of the consistency evaluation work, the State Administration organized and issued 21 supporting documents, established a consistency evaluation expert committee composed of authoritative experts, and deliberated on core issues such as the selection of reference preparations According to the record of reference preparations issued by CFDA, 5634 reference preparations were received Reporters visited provincial bureaus and learned that Guangdong, Zhejiang, Jiangsu, Fujian, etc are at the forefront In the first half of the year, Guangdong Province has completed 421 standards for reference preparations for consistency evaluation of quality and efficacy of generic drugs, which is the largest number of provinces and cities at present; there are 31 Enterprises in Shanghai with 108 specifications for reference reagents; 267 generic drug numbers in Zhejiang Province have started consistency evaluation; 396 varieties in Fujian Province plan to carry out consistency evaluation Anhui, Shandong, Sichuan and other provinces use the award and subsidy policies to encourage enterprises to carry out consistency evaluation Anhui Province has set up a platform for government, industry, education and research, and the government has issued a subsidy policy of 1 million to 3 million yuan There are 19 enterprises and 51 varieties in the province that have carried out the consistency evaluation Shandong Province has promoted the finance to set up a provincial subsidy policy for the consistency evaluation of generic drugs, giving awards to the top three enterprises that have passed the evaluation of the same variety, and the highest single variety award in Jinan City is 4 million yuan In the province, 347 varieties have started the consistency evaluation, and 50 varieties have completed the in vitro pharmaceutical research Sichuan Province will give 1-2 million rewards to each of the top three varieties that have passed the consistency evaluation Some provinces and cities that started their work later are also speeding up their work at present At present, Jiangxi province assists and guides 13 enterprises and 25 key varieties to carry out generic drug consistency evaluation; Chongqing city has to complete more than 380 approvals by the end of 2018, and 76 have been started; 25 drug manufacturers in Liaoning Province have started the consistency evaluation research, involving 79 approval numbers In view of the overall situation of the current work, experts at the meeting made it clear: "from the current registration and declaration situation, the goal of structural adjustment of drug number is expected to be achieved without reducing the number of varieties."
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