Analysis and suggestions on the registration path of Traditional Chinese Medicine products in Sweden
10.3760/cma.j.cn115398-20210509-00068
- VernacularTitle:中药产品在瑞典的注册路径分析与建议
- Author:
Haiming CAO
1
;
Tong LIU
;
Wenjing XU
;
Weihui LYU
;
Wei JIANG
;
Xiaoqing LI
;
Jiaqi WANG
Author Information
1. 广东省中医院二沙岛医院心血管心衰中心，广州 510105
- Keywords:
Registration of Traditional Chinese Medicine;
Traditional Chinese Medicine products;
Sweden;
Regulations;
Strategy
- From:
International Journal of Traditional Chinese Medicine
2022;44(6):606-609
- CountryChina
- Language:Chinese
-
Abstract:
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.
