In order to steadily promote the construction of food and drug supervision informatization, and implement the "State Food and Drug Administration on Further Strengthening Food and Drug Administration Guiding Opinions on the Construction of Regulatory Informatization (SFDA [2013] No. 32), to promote the interconnection, information sharing and business collaboration of food and drug regulatory information systems. , and organized the preparation of 10 food and drug supervision information standards such as the food and drug supervision information standard system in advance. It is now published on the official website of the General Administration of Food and Drug Administration and is invited to be adopted by food and drug regulatory departments at all levels. In the preparation process, the General Administration adopts the principle of open-door preparation, fully draws on the experience of relevant ministries and commissions, carefully listens to the opinions of authoritative experts in related fields, and solicits opinions from within the food and drug supervision system through various methods such as holding special meetings and printing and sending drafts for comments. , publicly solicited social opinions through the official website of the General Administration, and at the same time organized an expert review meeting to demonstrate the 10 standards.

The 10 standards released this time include the food and drug supervision informatization standard system and the food and drug supervision informatization foundation Terminology (information technology, drugs, and medical devices), food and drug regulatory information classification and coding specifications, basic data elements of food and drug regulatory information (general principles, institutional personnel, drugs, and medical devices), value ranges of basic data elements of food and drug regulatory information Codes (General Rules, Institutional Personnel, Drugs, and Medical Devices), Metadata Specifications for Food and Drug Administration Information Datasets, Interface Specifications for Food and Drug Administration Data Sharing and Exchange, General Technical Specifications for Food and Drug Administration Application Support Platforms, and Design Specifications for Food and Drug Administration Databases And food and drug supervision software development process specification.

The implementation of these 10 informatization standards is an important measure for the Administration to strengthen the top-level design of informatization construction. An important basis for food and drug informatization standards and specifications is the basic guarantee for the realization of food and drug regulatory information system interconnection, information sharing, and business collaboration. It plays a very important role in promoting the healthy and orderly development of food and drug supervision informatization.

Food and drug regulatory departments at all levels should actively adopt 10 standards in the construction of informatization. The information system should gradually transition to the standard specification according to the actual situation. The General Administration will closely combine the actual situation of informatization work and make timely revisions according to the implementation of the standards. It will continue to organize the formulation and improvement of informatization standards, and continuously improve the food and drug supervision informatization standard system.