Shijiazhuang No.4 Pharmaceutical Co., Ltd. leads MAH enterprise, and Qilu and Huahai are "spokesmen" of consistency evaluation enterprises

In order to fully mobilize the enthusiasm of R & D personnel and promote drug innovation, optimize resource allocation and inhibit low-level repeated construction, implement the main responsibility of enterprises, strengthen drug quality management and improve drug quality, innovate drug governance mechanism, give full play to the role of government, enterprises and market in strengthening drug management, and allow the drug listing license holders to be separated from the production enterprises , the system of drug marketing license holders has emerged The system of drug listing license holder usually refers to the system that the drug R & D institutions, scientific researchers, drug manufacturing enterprises and other subjects with drug technology apply for drug listing license and obtain the approval documents of drug listing license, and bear the main responsibility for the quality of drugs in the whole life cycle Under this system, the holder of listing license and the holder of production license can be the same subject or two independent subjects According to their own conditions, the holders of the listing license can produce by themselves or entrust other production enterprises with production In August 2015, the State Council issued the opinions on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), which opened the curtain of deepening the reform of China's drug regulatory system At the 17th meeting of the Standing Committee of the 12th National People's Congress, which closed on November 4, 2015, the State Council was authorized to carry out a three-year pilot drug listing license holder system in ten provinces and cities, including Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan On May 26, 2016, the general office of the State Council officially released the pilot program of drug listing license holder system, which was officially launched as the key play to deepen the reform of drug regulatory system The three-year pilot work of the drug listing license holder system has achieved remarkable results Recently, in order to fully and timely grasp the relevant information of drug listing license holders, the drug listing license holder database of the State Food and drug administration was launched online At the same time, the pharmaceutical intelligence network, which has been deeply involved in pharmaceutical data for more than ten years, coincides with the State Food and drug administration The pharmaceutical intelligence data enterprise version of China's listed drug database has successfully embedded and updated the sub database "listing license holder", and has recently been online The pilot expansion covers 11 provinces and cities across the country, and Hebei Province has led the way in collecting 3292 MAH approval numbers as of August 9, involving 1720 drugs belonging to 166 listed license holders In particular, according to the current data analysis, in addition to the first ten provinces (cities) of the pilot, Shaanxi Province has also joined in it and gradually expanded to the whole country; up to now, the pilot work of drug listing license holder system has covered 11 provinces and cities in the country, with Hebei Province at the forefront, with a total of 1254 approvals, followed by Guangdong and Jiangsu, with 890 and 511 approvals respectively Data source: Top 10 listing license holders in the database of pharmaceutical intelligence listing license holders, Shijiazhuang No.4 Pharmaceutical Co., Ltd is the first in the list of pharmaceutical enterprises, with 211 listing license documents held by Shijiazhuang No.4 Pharmaceutical Co., Ltd., followed by Hebei Anguo Pharmaceutical Group Co., Ltd and Beijing Yadong Biological Pharmaceutical Co., Ltd., with 180 and 161 approval document numbers respectively It is worth mentioning that 92% of the approvals held by Shijiazhuang No.4 Pharmaceutical Co., Ltd are chemical drugs, 95% of the approvals of Hebei Anguo Pharmaceutical Co., Ltd are traditional Chinese medicine, and 94% of the approvals of Beijing Yadong bio Pharmaceutical Co., Ltd are traditional Chinese medicine Data source: there are only 14 biologicals in the database of marketing license holders of pharmaceutical intelligence, and more than half of them belong to Yadong biologicals From the perspective of drug type, the drug listing license holder system covers a wide range of chemicals, traditional Chinese medicine and biological products 68% of the approvals held by listed license holders are chemicals; 31% are traditional Chinese medicine; 1% are biological products, with a total of 14 approval numbers Data source: database of pharmaceutical intelligence marketing license holders Among them, 14 approval documents for biological products, Beijing Yadong biopharmaceutical Co., Ltd accounted for 8; Xinda biopharmaceutical Co., Ltd was both the licensed holder and the manufacturer of cindilimab injection; the famous innovation driven biopharmaceutical company Junshi biopharmaceutical's treprizumab injection was produced by Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd More details can be found in the following table: data source: it should be noted that the manufacturer and the licensee are likely to be the manufacturer of the original approval number of the drug purchased by the licensee or the owner of the approval number is a subsidiary established by the Licensee Finally, it has to be mentioned that according to the database of drug intelligence marketing license holders, 117 of the 3292 MAH approval numbers as of August 9 have passed the consistency evaluation, including 48 deemed approval numbers and 69 approved supplementary evaluations There are 69 varieties involving 45 drug listing license holders in total, among which Qilu pharmaceutical and Zhejiang Huahai pharmaceutical, as the leading enterprises in consistency evaluation, are still at the forefront again Qilu pharmaceutical has 15 approvals (10 varieties) and Huahai pharmaceutical has 10 approvals (5 varieties) that have been reviewed and approved by consistency evaluation, which enter the database of listing license holders See the table below for more details : the database of marketing license holders through the consistency evaluation of drug detail table data source: the database of marketing license holders of pharmaceutical intelligence creates a database of each affiliated industry, provides the best and most convenient data query service for pharmaceutical people, and enters the database of pharmaceutical intelligence enterprises in China (https://vip.yaozh.com/cfdadrug ）, click Advanced search, find the answers you need, and give you a different surprise experience! Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.