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    Home > Active Ingredient News > Drugs Articles > Progress of generic consistency evaluation in the first half of 2019: 2.7x accelerated over evaluation

    Progress of generic consistency evaluation in the first half of 2019: 2.7x accelerated over evaluation

    • Last Update: 2019-08-01
    • Source: Internet
    • Author: User
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    The first one of Huoshi Research Institute, policy background, and Drug Administration announced that the generic drugs including essential drugs approved for listing before the implementation of new registration and classification of chemical drugs After the first varieties passed the consistency evaluation, the same varieties of other drug manufacturers should be evaluated within 3 years in principle In June 2015, the opinions of the general office of the State Council on the evaluation of the consistency of the quality and efficacy of generic drugs stipulated that the consistency evaluation should be completed by the end of 2018 in principle for the chemical generic oral solid preparations approved for marketing before October 1, 2007 and listed in the catalogue of national essential drugs (2012 Edition) On December 28, 2018, the State Food and Drug Administration officially issued a document to cancel the requirement of completing the quality and efficacy consistency evaluation of generic drugs by the end of 2018 for some varieties in 289 original drug catalogs As of the first half of 2019 (H1), 224 varieties in China have passed the consistency evaluation (including 59 deemed varieties) This year, 95 new products have been evaluated, and the rate of over evaluation is 2.7 times of the same period in 2018 2、 Variety analysis (I) over evaluated varieties by time distribution 1 The acceptance rate of consistency evaluation drugs in China is faster than that of approved drugs According to the flint creation database, in H1 2017-2019, the number of approval documents approved to pass the conformity assessment of generic drugs in China reached 376, the number of drugs reached 224 (including 59 deemed approved varieties), involving 127 varieties and 14 types of indications; there were 1214 acceptance numbers of conformity assessment accepted by CDE, 912 drugs, involving 362 varieties and 25 types of indications In 2017, 2018 and 2019, the number of H1 approved products was 15, 114 and 95 respectively, while the number of drugs accepted was 45, 442 and 425 respectively Figure 1 data source of approval and acceptance of H1 drugs in 2017-2019: flint creation 2 The approval and acceptance of H1 drugs in 2019 shows an overall downward trend In the first half of 2019, the number of products passing the national generic drug conformity assessment remained at a high level, but showed a slow downward trend, especially in June, the number of products passing the assessment was significantly lower than the average level of the first five months, and the acceptance volume had a significant downward trend since the start of the year when it reached a record high According to the flint creation database, the month with the largest number of approval for consistency assessment in H1 from 2017 to 2019 is December 2018 (32); since February 2019, the number of approved drugs has decreased month by month, to June, only three products have been approved, which is the lowest since October 2018 The most accepted month of drugs is January 2019 (164), and after January, the accepted amount shows a downward trend The number of drugs accepted in June was 40, the lowest since August 2018 Figure 22017 - data source of approval and acceptance of H1 monthly consistency evaluation drugs in 2019: huoshichuang (II) distribution by variety 1 Annual change of evaluated drugs According to the database of Huoshi creation, in H1 2017-2019, there were 127 varieties and 224 products approved for conformity assessment of generic drugs in China, an increase of 49% and 74% respectively compared with the end of 2018; the average number of products under evaluation of each variety was 1.8 (an increase of 0.3 products compared with the end of 2018), 45 varieties exceeding the average, accounting for 35% of the total varieties, and the number of products under evaluation It is 142, accounting for 63% of the total products Among them, "tenofovir dipivoxil fumarate tablets" is the most reviewed product, with 9 reviewed products; 22 varieties with 3 or more reviewed products, 10 more than the end of 2018; only one product has 82 approved varieties, accounting for 65% of all reviewed products, 7% lower than the end of 2018 Fig 3 data source of varieties with the number of evaluated products greater than or equal to 3: flint creation 2 New approved varieties According to the Firestone creation database, in 2019, the number of new products that have been evaluated in H1 reached 42, and the number of products that have been evaluated in 11 varieties exceeded 1 The most products that have been evaluated are the anti infective drug "isoniazid tablets" The production enterprises include Yichang humanwell Pharmaceutical Co., Ltd., Shenyang Hongqi Pharmaceutical Co., Ltd., Huazhong Pharmaceutical Co., Ltd and Guangdong South China Pharmaceutical Co., Ltd Isoniazid tablet is an anti tuberculosis drug In 2018, the sales volume in China is about 94 million yuan At present, there are 381 domestic isoniazid tablet manufacturers, 10 of which have accepted the application for conformity assessment, and a large number of manufacturers will be eliminated in the market due to failing to pass the conformity assessment Table 1 data source of newly approved drugs for consistency evaluation in the first half of 2019: Huoshi creation 3 According to the database of Huoshi creation, the number of drugs that passed the consistency evaluation for the first time in 2017 was 13, that is to say, CDE will not accept the application for consistency evaluation of other drug manufacturers after 2020 In 2018, the number of first evaluated varieties is 72, that is, CDE will no longer accept the consistency evaluation application of other drug manufacturers' 72 varieties after 2021; in 2019, the number of first evaluated varieties is 42, that is, CDE will no longer accept the consistency evaluation application of other drug manufacturers' 42 varieties after 2022 Among them, the manufacturers of rosuvastatin calcium tablets and gefitinib tablets (Zhengda Tianqing was approved for listing on May 21, 2019, deemed to have passed the consistency evaluation) have all passed the consistency evaluation In addition, Zhejiang Huahai pharmaceutical industry has strong advantages in terms of variety layout, preemption and exclusivity Table 2 first evaluated varieties in 2017 (product warning in 2020) data source: flint creation (III) by enterprise distribution According to Firestone creation database, as of the first half of 2019, 224 generic products of 117 enterprises in H1 2017-2019 have passed the consistency evaluation, with an average of 1.9 over evaluated products per enterprise, 39 enterprises exceeding the average, accounting for 33% of the total enterprises, 146 over evaluated products, accounting for 65% of the total products Among them, the enterprises with the largest number of evaluated products include Qilu Pharmaceutical (12), Zhejiang Huahai Pharmaceutical (11), Haosen Pharmaceutical (8), Shiyao Ouyi (8), Jiangsu Hengrui (7), Sichuan Kelun (7), etc., with the number of evaluated products reaching 53, accounting for 24% of the total; the enterprises with the largest number of evaluated products, 78, accounting for 67% of the total % In 2019 H1, 45 new enterprises were evaluated, accounting for 38% of the total number of enterprises evaluated In the first half of 2019, the enterprises with a large number of evaluated products are Qilu Pharmaceutical (7), Yichang humanwell Pharmaceutical (4), Haosen Pharmaceutical (3), Ouyi (3), Sichuan Kelun (3), Shenzhen xinlitai (3), Zhengda Tianqing (3) Fig 3 data source of enterprises with H1 product number > 2 in 2017-2019: Huoshi creation (IV) regional distribution 1 Urban evaluation According to Firestone creation database, 224 generic drugs from 51 cities passed the consistency evaluation in H1 2017-2019, with an average of 4.4 drugs reviewed in each city, including 15 cities above the average, accounting for 29% of the total number of enterprises, 159 products reviewed, accounting for 71% of the total number of products Among them, Lianyungang (21), Chengdu (20), Taizhou (14), Jinan (13), Shijiazhuang (12), Chongqing (11), Beijing (10), Hangzhou (10) and other eight cities have the largest number of evaluated products (111), accounting for 50% of the total number of evaluated drugs in China There are 14 cities with only one evaluated product, accounting for 29% of the total number of enterprises In H1 2019, 14 new generic consistency evaluation cities were added, including Nantong (2), Xuzhou (2), Changsha (2), Foshan (1), Fuzhou (1), Guiyang (1), Huai'an (1), Jining (1), Jieyang (1), Putian (1), Tongling (1), Xiangyang (1), Yiyang (1) and Yuncheng (1), accounting for all the evaluation cities 27% (14 / 52) of the city In 2019, Lianyungang (8 cities), Chengdu (7 cities), Jinan (7 cities), Shijiazhuang (6 cities), Beijing (5 cities) and Yichang (5 cities) added the most products Figure 4 data sources of cities with more than 2 National generic drug consistency evaluations in 2017-2019: flint creation 2 Province (city, autonomous region) over evaluation According to the database of Huoshi creation, 21 provinces of generic drugs have passed the consistency evaluation in H1 2017-2019, among which Jiangsu (49), Zhejiang (29), Sichuan (24), Guangdong (21), Shandong (21) and other five provinces have the largest number of drugs reviewed, 144 in total, accounting for 64% of the country Figure 5 data sources of products reviewed in H1 provinces of national generic conformity assessment in 2017-2019: Huoshi chuang3 Summary to sum up, in the first half of 2019, the number of products passed the national generic conformity assessment remained at a high level, with 95 products reviewed in half a year, accounting for 83% of the total number of products reviewed in 2018; the number of new varieties, enterprises and cities reviewed increased significantly In addition, the concentration of products over evaluated is still very high, and the regional concentration of products over evaluated is the highest: 29% of cities over evaluated have more than the average number of products over evaluated, accounting for 71% of the total number of products over evaluated, 33% of enterprises over evaluated have more than the average number of products over evaluated, accounting for 65% of the total number of products over evaluated, accounting for 63% of the total number of products over evaluated.
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