156 enterprises are included in the database of drug marketing license holders

On August 2, the State Food and Drug Administration released the database of drug listing license holders, which currently includes 156 enterprises and 3239 varieties The details are as follows: carrying out the pilot of drug listing license holder system is an important part of the reform of drug review and approval system, which is of great significance to encourage drug innovation and improve drug quality In order to fully and timely grasp the relevant information of drug listing license holders, the information center, under the guidance of relevant business departments and bureaus, has built a drug listing license holder database (hereinafter referred to as the holder database) on the national drug regulatory data sharing platform Relevant business departments, directly affiliated units and provincial regulatory departments can query the relevant data of drug listing holders through the data sharing platform The holder database is the key construction content of the new database project of the sharing platform in 2019, and it is also a typical application scenario of drug variety archives According to the principles of standardization, standardization, structure and expansion, the database collects and displays the information of approved drug listing license holders and their varieties By the end of July 2019, it has included 3239 varieties (calculated by drug approval number) of listed license holders, and 156 subjects of listed license holders 1、 Data collection is comprehensive, accurate and authoritative The holder database is composed of two sub databases, i.e the main information database of drug listing license holders and the variety database of drug listing license holders The information covers the main information of drug listing license holders and the specific variety information, realizing multi-dimensional data collection The holder data is based on the information mark of the listing license holders stated in the approval conclusion of the drug approval certificate document to ensure the data right The data source covers all the approval documents issued by the National Bureau and provincial drug regulatory authorities, which makes the data comprehensive, accurate and authoritative 2、 Strengthen the integration of information and realize the related display of multi-source information The information center gives full play to the advantages of big data resource pool On the basis of collecting the basic information of the holders and their varieties, it links the contents of drug manufacturing enterprises, consistency evaluation information, variety pharmacology and functional classification, management attribute, enterprise territory, etc., breaks the information island, makes the data connect with each other, and lays the foundation for making full use of the data in the supervision work 3、 Provide a friendly query statistics interface, improve user experience, improve data statistics query function, provide fixed query and user-defined query and their combination query mode, and facilitate users to set their own search conditions according to their needs Establish horizontal association between databases to facilitate users to query association data from any entry of the holder's main body and the holder's variety with one key, and the query experience is good In the background management, the data content display form, field order, query conditions and other settings can be configured flexibly basically, without changing the source code, and maintenance is flexible and extensible 4、 Optimize the authority configuration, strengthen the data sharing publicity, increase the data download function according to the authority, and provide comprehensive data services for the regulatory authorities Users in the system can log in to the national drug regulatory application integration and data sharing platform for query (see Figure 1 and Figure 2) to realize co construction and sharing At the same time, the product information of the listing license holder is pushed to the drug approval number database of the State Administration to realize linkage with the government website of the State Administration The public can search through the data query column on the website of the State Administration (see Figure 3), provide accurate and comprehensive data query services for the holders, realize information disclosure, and make enterprises and the public feel more accessible Next, the information center will rely on the supervision business to strengthen the construction of the holder database, focusing on improving the timeliness of data update, expanding relevant drug attribute data resources, and strengthening data mining and analysis, so as to provide better data support and services for the reform of drug review and approval system Figure 1 National drug regulatory application integration and data sharing platform Figure 2 Shared platform drug listing license holder database Figure 3 Original title of drug listing license holder data query on the website of the State Administration: drug listing license holder database is online, currently including 156 enterprises and 3239 varieties