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State Food and Drug Administration issued 10 food and drug supervision information standards

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[Abstract]:
Food and Drug Administration to steadily push forward the construction of information technology , the implementation of "State Food and Drug Administration guidance on further strengthening the Food

Food and Drug Administration to steadily push forward the construction of information technology , the implementation of "State Food and Drug Administration guidance on further strengthening the Food and Drug Administration information technology " (State Food and Drug Administration Office [ 2013 ] No. 32 ) , to promote the food and drug regulatory information system interoperability, information sharing and business collaboration , the State food and Drug Administration of the actual needs , in accordance with the principles of urgently -first , the initial organization prepared 10 food and drug supervision information technology standards for food and drug regulatory system and other information technology standards . Now through the official website of the General Administration of publishing, food and drug supervision departments at all levels adopted . In the preparation process, the Administration prepared to take the principle of open , fully draw on the experience of relevant ministries , listened carefully to the views of experts in related fields , through the convening of a special meeting , India and several other methods to send the draft to seek the views of the food and drug regulatory system openly solicit public views through the official website of the General Administration also organized the expert review of 10 standards were demonstrated .

 

10 standards in this release , including food and drug supervision information technology standards, information-based food and drug supervision term ( IT , pharmaceuticals, medical devices ) and food and drug regulation information classification and coding standards , food and drug regulatory information infrastructure data yuan ( General , agency personnel , medicines, medical devices ) and food and drug regulation range of information -based data element code ( General , agency personnel , medicines, medical devices ) and food and drug regulatory information data set metadata specification , food and drug regulation data sharing and exchange interface specification , food and drug regulatory application support platform common technical specification, database design, food and drug regulatory norms and food and drug regulatory software development process specification.

 

This 10 standard implementation of information technology is an important measure to strengthen the information technology Administration of the top-level design is unified food and drug information is an important basis for standards , is the basis for food and drug regulatory information system interoperability, information sharing, business collaboration protection. The promotion of food and drug supervision healthy and orderly development of information technology play a very important role .

 

Food and drug supervision departments at all levels of information technology to be actively using 10 criteria have been built for the use of information systems should be a gradual transition to standards based on the actual situation . Administration will work closely practical information , in accordance with the implementation of standards, timely revision . And will continue to organize information to develop and improve the standard of work , and constantly improve the standard of food and drug supervision information system .