Abstract: Objective To map and transform the "National Adverse Drug Reaction Terminology" to MedDRA. Methods Based on "National Adverse Drug Reaction Terminology" "MedDRA version 21.0" "UMC-Bridge" and so on, using"one term three codes" technological route to map and match the "national adverse drug reaction terminology" to MedDRA. If the codes found by different routes were the same, then mapping relationship was almost determined. If the codes found by different routes were different or only one code was found, then mapping relationship need to be reviewed artificially. If no code was found, the term needed to be coded by external experts. Results Of the 6 717 terms, 2 733 terms were basically determined, 3 175 terms need to be manually reviewed, and 809 terms needed to be manually coded by external experts. Conclusion The mapping and transformation of "National Adverse Drug Reaction Terminology" to MedDRA can be realized by adopting this technological route. In order to promote the application of MedDRA in China and facilitate the implementation of the direct reporting system, it is suggested to establish a coordination mechanism with MSSO to improve the accuracy of the Chinese version, establish the Chinese glossary of adverse drug reactions (C-ART) and guide for the filling of adverse drug reaction terms, etc.

Key words: MedDRA, National Adverse Drug Reaction Terminology, ADR Direct Reporting System