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The State Food and Drug Administration issued 10 food and drug regulatory information standards

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[Abstract]:
In order to steadily promote the informationization of food and drug supervision, and implement the “Guiding Opinions of the State Food and Drug Administration on

In order to steadily promote the informationization of food and drug supervision, and implement the “Guiding Opinions of the State Food and Drug Administration on Further Strengthening the Informatization Construction of Food and Drug Regulations” (Guo Food and Drug Administration [2013] No. 32), promote the Food and Drug Administration Information System Interconnection, information sharing and business collaboration, the State Food and Drug Administration, in accordance with the actual needs, in accordance with the principle of urgency, first organized the preparation of food and drug regulatory information standard system and other 10 food and drug regulatory information standards. It is now published through the official website of the General Administration and is requested by the food and drug supervision departments at all levels. In the process of preparation, the General Administration adopted the principle of opening the door, fully drawing on the experience of relevant ministries and commissions, carefully listening to the opinions of authoritative experts in relevant fields, and soliciting opinions from the food and drug supervision system through various meetings such as holding special meetings and printing drafts for comments. Through the official website of the General Administration of the People's Republic of China, public consultation was conducted, and an expert review meeting was organized to demonstrate the 10 standards.

 

The 10 standards issued this time include the food and drug regulatory information standard system, the basic terminology of food and drug supervision information (information technology, drugs, medical devices), food and drug regulatory information classification and coding standards, food and drug regulatory information basic data. Yuan (general, institutional personnel, drugs, medical equipment parts), food and drug regulatory information basic data element value code (general rules, institutional personnel, drugs, medical devices), food and drug regulatory information data set metadata specifications, food and drug supervision Data sharing and exchange interface specifications, general technical specifications for food and drug regulatory application support platforms, 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 for the General Administration to strengthen the top-level design of informatization construction. It is an important basis for unifying the standardization of food and drug informatization standards, and is the basis for realizing the interconnection and interoperability of food and drug regulatory information systems, information sharing and business synergy. Guarantee. It plays a very important role in promoting the healthy and orderly development of food and drug supervision information construction.

 

Food and drug supervision departments at all levels must actively adopt 10 standards in the construction of information technology. For information systems that have already been built and used, they should gradually transition to standard specifications according to actual conditions. The General Administration of the People's Republic of China will closely combine the actualization of informationization work and timely revision according to the implementation of the standards. It will continue to organize the development and improvement of information technology standards and continuously improve the food and drug regulatory information standard system.