Current situation and suggestions concerning the implementation of MedDRA in drug monitoring in China

doi:10.19803/j.1672-8629.20240103

Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (7): 746-751.
DOI: 10.19803/j.1672-8629.20240103

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Current situation and suggestions concerning the implementation of MedDRA in drug monitoring in China

ZHU Yan¹, LI Qingna², ZHU Lan³, XIE Jiang’an⁴, YAO Keyu¹, HUANG Guangrui⁵, YANG Xiaolin^6#, GUAN Jian^7,*

¹Institute of Information on Traditional Chinese Medicine, CACMS, Beijing 100700, China;
²Institute of Clinical Pharmacology, Xiyuan Hospital of China, Academy of Chinese Medical Sciences, Beijing 100091, China;
³Center for Drug Reevaluation, NMPA/NMPA, Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
⁴College of Bioinformatics, Chongqing University of Posts and Telecommunications, Chongqing 400065, China;
⁵School of Life Sciences, Beijing University of Traditional Chinese Medicine, Beijing 102488, China;
⁶Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, Beijing 100005, China;
⁷Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, The National Population Health Data Center (Clinical Medicine), Beijing 100730, China

Received:2024-02-22 Online:2024-07-15 Published:2024-07-31

Abstract

Abstract: Objective To point out the problems with and challenges to the implementation of the Medical Dictionary for Regulatory Activities (MedDRA) in drug monitoring in China in order to provide reference for applications of MedDRA. Methods MedDRA was outlined. Issues and challenges facing the product itself, management mechanisms, training of users, and construction of the community of users were analyzed. Countermeasures were recommended, such as improving management mechanisms, expanding the Chinese version, building a shared coding case database, continuous review and improvement of the Chinese version of MedDRA, supplementing definitions, and increasing the content of traditional Chinese medicine. Results and Conclusion With collaborated efforts, the introduction, popularization, and implementation of MedDRA started smoothly. Due to such factors as the characteristics of MedDRA products and existing management mechanisms, there were several issues and challenges. All parties concerned needed to coordinate and work together to address related issues and challenges to make MedDRA compatible with internationally-accepted practices and achieve mutual recognition, and to promote the high-quality development of innovative drugs in China.

Key words: MedDRA, terminology, drug, postmarketing, surveillance

CLC Number:

R951

ZHU Yan, LI Qingna, ZHU Lan, XIE Jiang’an, YAO Keyu, HUANG Guangrui, YANG Xiaolin, GUAN Jian. Current situation and suggestions concerning the implementation of MedDRA in drug monitoring in China[J]. Chinese Journal of Pharmacovigilance, 2024, 21(7): 746-751.

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Current situation and suggestions concerning the implementation of MedDRA in drug monitoring in China

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