中国中西医结合杂志2024，Vol.44Issue(11)：1295-1300,6.DOI:10.7661/j.cjim.20240910.275
中成药在英国注册上市路径与方法
Approach of Registering Chinese Patent Medicine in the United Kingdom
摘要
Abstract
The 14th Five-Year Plan for the development of Chinese medicine(CM)emphasized the importance of expanding international trade in CM,enhancing policy and regulatory cooperation with overseas countries,facilitating product registration and market access,promoting the registration of CM products overseas,and supporting the global expansion of CM enterprises.Europe is the largest export markets for CM,with the United Kingdom(UK)being the primary sales destination for CM in Europe.However,the approval of Chinese patent medicine in the UK remains relatively limited.This research based on a Sino-UK joint project on Chinese medicine,the authors introduced the regulatory status of herbal products in the UK.Furthermore,the authors delved into the three sales channels,five registration paths,and their applicable conditions.The authors also analyzed the indications,methods and material preparation of the Traditional Herbal Registration for Chinese patent medicine.This research offers direction for policy making,academic research and market analysis in China,while also serves as a reference for the oversea registration of CM products,particularly Chinese patent medicine in the future.关键词
中成药/草药产品/注册上市/传统草药注册Key words
Chinese patent medicine/herbal products/listing/Traditional Herbal Registration引用本文复制引用
蔡祎晴,胡晓阳,夏如玉,费宇彤,刘建平..中成药在英国注册上市路径与方法[J].中国中西医结合杂志,2024,44(11):1295-1300,6.基金项目
国家重点研发计划项目(No.2018YFE0102300) （No.2018YFE0102300）
国家中医药管理局高水平中医药重点学科建设项目(No.zyyzdxk-2023249) （No.zyyzdxk-2023249）
