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.
维普
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