中药产品在瑞典的注册路径分析与建议

Analysis and suggestions on the registration path of Traditional Chinese Medicine products in Sweden

瑞典医药管理局(MPA)现有法规和制度对医药产品的定义、分类及上市流程有明确规定,审查方面严格遵循欧盟规范。中药产品属瑞典草药产品(HMP)或传统草药产品(THMP)范畴,由瑞典医药产品管理局(MPA)管理。本文分析了中药产品在瑞典的注册归类、相关规定及注册流程,建议中药企业在申请中药产品上市前需全面理解欧盟法规和指导条例,明确产品类别,并提供充分、准确的证据,申请过程中应注意与瑞典药监部门加强沟通。

The existing regulations and systems of the Swedish Medical Products Agency(MPA)have clear provisions on the definition,classification and listed on the market procecure of pharmaceutical products,and the supervision strictly follows the EU standards.Traditional Chinese Medicine(TCM)products belong to the category of Swedish Herbal Medicine Products(HMP)or Traditional Herbal Medicine Products(THMP)and are under the supervision of Swedish Pharmaceutical Products Administration(MPA).This paper analyzes the classification,relevant regulations and registration procecures of TCM products in Sweden.It is suggests that TCM enterprises should fully understand the EU regulations and guidance regulations before listed on the market of TCM products.They should also clarify the product category,and provide sufficient and accurate evidence.In the application process,they should pay attention to strengthening communication with the drug administration units of Sweden.