Study on Applicability of ICH Guideline M1 Mapping Feasibility of National Adverse Drug Reaction Terminology

Abstract

Abstract: Objective To study the feasibility of mapping National Adverse Drug Reaction Terminology with MedDRA. Methods The applicability of MedDRA in China is studied through comparative analysis, questionnaire survey and expert interview. Result sand Conclusion It is feasible to establish the mapping relationship between National Adverse Drug Reaction Terminology and MedDRA, which is a powerful measure to implement the ADR Direct Reporting System.

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

CLC Number:

R994.11

MA Danhua, LIU Hongliang, WANG Dan, LI Ming, TIAN Chunhua. Study on Applicability of ICH Guideline M1 Mapping Feasibility of National Adverse Drug Reaction Terminology[J]. Chinese Journal of Pharmacovigilance, 2019, 16(6): 329-332.

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