In order to steadily advance the construction of food and drug supervision information, implement the "Guiding Opinions of the State Food and Drug Administration on Further Strengthening the Construction of Food and Drug Supervision Information" (State Food and Drug Administration [2013] No. 32), and promote the food and drug supervision information system For interconnection, information sharing, and business coordination, the State Food and Drug Administration, based on actual needs and in accordance with the principle of urgent use first, organized the preparation of 10 food and drug regulatory information standards including the food and drug regulatory information standard system. It is now released through the official website of the State Administration of Taxation, and the food and drug regulatory authorities at all levels are invited to adopt it. In the process of preparation, the State Administration adopted the principle of open-door preparation, fully learned from the experience of relevant ministries and commissions, carefully listened to the opinions of authoritative experts in related fields, and solicited opinions from the food and drug regulatory system through various methods such as holding special meetings and printing and sending the draft for comments. , Through the official website of the General Administration of Public Solicitation of social opinions, and at the same time organized an expert review meeting to demonstrate 10 standards.

　　The 10 standards released this time include the food and drug regulatory informatization standard system, the basic terminology of food and drug regulatory informatization (information technology, drugs, and medical devices), the classification and coding standards for food and drug regulatory information, and the basic data of food and drug regulatory information Meta (General Provisions, Institutional Staff, Drugs, Medical Devices), Element Value Range Code of Basic Data of Food and Drug Supervision Information (General Provisions, Institutional Staff, Drugs, and Medical Devices Section), Metadata Specification for Food and Drug Supervision Information Data Sets, Food and Drug Supervision Data sharing and exchange interface specifications, food and drug regulatory application support platform general technical specifications, food and drug regulatory database design specifications, and food and drug regulatory software development process specifications.

　　The implementation of these 10 informatization standards is an important measure taken by the General Administration to strengthen the top-level design of informatization construction, an important basis for unifying food and drug informatization standards and norms, and a foundation for the interconnection, information sharing, and business collaboration of food and drug regulatory information systems Assure. It plays a very important role in promoting the healthy and orderly development of food and drug supervision informatization.

　　Food and drug regulatory authorities at all levels should actively adopt 10 standards in the construction of informatization. For information systems that have been built and used, they should gradually transition to standards and norms based on actual conditions. The General Administration will closely combine the actual situation of informatization work and make timely revisions based on the implementation of the standards. It will continue to organize the formulation and improvement of informatization standards, and continue to improve the food and drug regulatory informatization standard system.