Drug annual report system officially implemented, the whole network office channel simultaneously opened


Release time:

2022-04-18

In order to implement the relevant requirements of the newly revised Drug Administration Law and the measures for the Supervision and Administration of Drug production, and to establish a scientific and strict drug supervision and management system, on April 12, 2022, the State Food and Drug Administration formally issued the regulations on the Administration of Drug Annual reports. The annual drug report will serve as a reference material and basis for research and judgment for supervision and inspection, risk assessment, and credit supervision. In order to ensure that the new drug annual report system comes into effect, under the guidance and support of the Drug Supervision Department of the State Food and Drug Administration, the Information Center has successfully completed the development and construction of the drug annual report collection module, and will be launched simultaneously on the date of implementation of the system, which can realize online reporting.

In order to implement the relevant requirements of the newly revised Drug Administration Law and the measures for the Supervision and Administration of Drug production, and to establish a scientific and strict drug supervision and management system, on April 12, 2022, the State Food and Drug Administration formally issued the regulations on the Administration of Drug Annual reports. The annual drug report will serve as a reference material and basis for research and judgment for supervision and inspection, risk assessment, and credit supervision. In order to ensure that the new drug annual report system comes into effect, under the guidance and support of the Drug Supervision Department of the State Food and Drug Administration, the Information Center has successfully completed the development and construction of the drug annual report collection module, and it will be launched simultaneously on the date of system implementation, which can realize online reporting, Online submission and statistical inquiry and other functions. The module construction presents the following highlights:

1. closely linked to business needs, to achieve three functions

From the perspective of construction content, the drug annual report collection module is guided by the business needs of drug supervision, focuses on the accurate and efficient service industry, adheres to the equal emphasis on supervision and service, and truly realizes the annual report of "zero meeting" and "zero running errands" of enterprises. Save the cost and time of the enterprise.

First, the variety of associated binding, covering domestic and foreign enterprises. In order to facilitate the filling of domestic drug marketing license holders, the module automatically correlates the drug variety information held in their name. In order to implement the relevant requirements for overseas drug marketing license holders to entrust domestic agents to fill in information, the module adds functions such as basic information maintenance, variety binding and online filling of annual reports of domestic agents. At the same time, it accurately records the information of holders and agents of each annual report to ensure that overseas drug annual reports can be collected, submitted and queried.

The second is to refine the collection requirements and realize electronic management. From a macro point of view, according to the requirements of the drug annual report template, the information center refines the collection requirements, and through information means, the product information, production and sales, post-marketing research and change management, risk management and other contents in the drug annual report are all electronic, realizing the electronic, structured and modular management of the annual report, laying the foundation for the sharing and application of subsequent annual report data. From a micro point of view, the module has carefully written filling instructions for each part of the content, and supports filling functions according to two different granularity of drug varieties (common names) and specifications, so as to ensure that the module design meets the requirements and is practical and usable.

Three is based on real name registration, the implementation of the main responsibility of enterprises. Enterprises should register their real names to fill in the annual drug report, which ensures the authenticity and accuracy of the filling subject. At the same time, for the overseas production of drug marketing license holders in the territory of the entrusted agency behavior, the domestic agent needs to upload the power of attorney, fill in the basic information of the agent and bind the overseas drug varieties, before carrying out the overseas production of drug annual report filling work, to ensure the reliability and compliance of the entrusted agency behavior. Through this module, the holder of the domestic production drug marketing license or the domestic agent submits the drug annual report online to the local provincial bureau for the supervision department to inquire.

 

2. strengthen integration and sharing, to achieve a management

In accordance with the relevant policy requirements for the integration and sharing of the national government information system, the Information Center has expanded and constructed the drug annual report collection module with the help of the technical architecture and infrastructure of the drug business application system (information collection). At present, the drug business application system (information collection) and the drug business application system (approval and filing) have been deeply integrated into a large drug business application system, which has been docked with the online service hall of the State Food and Drug Administration, realizing the "one netcom" of all drug registration approval and filing and information collection services, and continuously optimizing public services. Drug regulators can access the drug business application system through the national drug intelligent supervision platform, realize the "one network unified management" of the above-mentioned business, avoid repeated login of multiple systems, and improve the efficiency of drug supervision.

3. insist on counting out one source to improve data quality

According to the relevant requirements of drug annual report management, the drug annual report covers the basic information of drug marketing license holders, basic information of drug varieties and production. In order to facilitate drug marketing license holders to fill in the form and reduce the burden of enterprises to fill in the form, the module automatically connects the approved drug variety registration and drug production license related information directly from the drug regulatory data sharing platform, thus realizing the automatic bringing out of key basic information, reducing the error rate of manual filling by users and further improving the quality of filling in the information.

In the next step, the information center will continue to optimize and improve the functions of the drug annual report collection module, and timely gather relevant data to drug variety files and drug safety credit files, accelerate the digital management of the whole life cycle of drugs, deepen the application of big data analysis, improve the ability of drug safety risk research and judgment, gradually realize accurate and scientific drug supervision, and effectively improve the efficiency of drug supervision.