Adverse drug reactions (ADR) are one important type of safety data for investigational products and post-market drugs. Standardized coding is beneficial to normative ADR analysis and reporting. However, terms peculiar to traditional Chinese medicine (TCM) are not included in the widely used international adverse reaction terminologies. This paper briefly introduced the differences of World Health Organization adverse reaction terminology (WHOART) and medical dictionary for regulatory activities (MedDRA) which was developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Based on the existing development of TCM terminologies for coding ADRs, basic path for developing internationally recognized TCM terminologies was proposed in this paper.
Citation：
LI Qingna, LU Fang, ZHAO Yang, LI Rui, ZHAO Yingpan, ZI Mingjie, TANG Xudong, GAO Rui. Development of coding terminologies on adverse drug reactions for traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2018, 18(11): 1169-1172. doi: 10.7507/1672-2531.201804073
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- 2. Anna ZW. MedDRA and MSSO Updates. Available at: https://www.meddra.org/user-groups.
- 3. 马丹华. MedDRA应用于药品安全性监测与评价的可行性研究. Available at: https://www.meddra.org/user-groups.
- 4. 李庆娜, 陆芳, 赵阳, 等. 构建基于MedDRA术语的中医临床试验编码术语集初探. 中国药物警戒, 2015, 12(1): 53-55.
- 5. 李溪. 基于MedDRA的中药新药临床安全性评价术语编码数据库研究. 北京: 北京中医药大学, 2012.
- 6. 全国科学技术名词审定委员会. 中医药学名词(1版). 北京: 科学出版社, 2005.
- 7. 中华人民共和国国家标准. 中医临床诊疗术语疾病部分(GB/T 16751.1-1997). 北京: 中国标准出版社, 1997.
- 8. 李庆娜. MedDRA and Traditional Chinese Medicine. Available at: https://www.meddra.org/user-groups.
- 9. WHO. The 11th Revision of the International Classification of Diseases. Available at: http://www.who.int/classifications/icd/revision/en/.
- 10. WHO regional office for the western pacific. WHO international standard terminologies on traditional medicine in the western pacific region. Available at: http://www.wpro.who.int/publications/PUB_9789290612483/en/.
- 11. 国家食品药品监督管理总局. 关于适用国际人用药品注册技术协调会二级指导原则的公告(2018年第10号). Available at: http://samr.cfda.gov.cn/WS01/CL0087/223345.html.
