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Analysis and suggestions on the registration path of Traditional Chinese Medicine products in Sweden / 国际中医中药杂志
International Journal of Traditional Chinese Medicine ; (6): 606-609, 2022.
Artículo en Chino | WPRIM | ID: wpr-954355
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.

Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Idioma: Chino Revista: International Journal of Traditional Chinese Medicine Año: 2022 Tipo del documento: Artículo

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Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Idioma: Chino Revista: International Journal of Traditional Chinese Medicine Año: 2022 Tipo del documento: Artículo