Traditional use and safety evaluation of combination Traditional Chinese Medicine in European registration: with XiaoYao Tablets as an example.
Pharmazie
; 77(3): 125-130, 2022 04 10.
Article
en En
| MEDLINE
| ID: mdl-35459442
ABSTRACT
Mental health disorders such as stress, anxiety, depression and insomnia caused by COVID-19 have attracted worldwide attention. Traditional Chinese medicines (TCMs) have been proven to be a safe and effective option for treating mental health disorders. Recently, after assessing its efficacy and safety fully, the Netherlands Medicines Evaluation Board approved XiaoYao Tablets as a traditional herbal medicinal product (THMP), indicated for an alternative self-care for patients in Europe to relieve the symptoms of mental stress and exhaustion. Despite the fact that TCMs have gradually become one of the therapeutic choices worldwide, to-date, only a few TCMs have been successfully registered in the European Union (EU) as THMPs, and XiaoYao Tablets is the first successfully registered combination TCM from China. In this article, traditional use efficacy and clinical safety of XiaoYao Tablets in the treatment of mental health disorders were summarized and analyzed from the perspective of traditional use registration (TUR). Additionally a safety evolution pathway of combination TCMs was established. This article will not only seek to enhance our understanding about traditional use efficacy and clinical safety of XiaoYao Tablets, but also summarize the experience of XiaoYao Tablets as the first successfully registered combination TCM from China, which could serve as role model for the others to overcome registration difficulties in the EU.
Texto completo:
1
Bases de datos:
MEDLINE
Medicinas Tradicionales:
Medicina_tradicional_de_europa
/
Medicinas_tradicionales_de_asia
/
Medicina_china
Métodos Terapéuticos y Terapias MTCI:
Terapias_biologicas
Asunto principal:
Medicamentos Herbarios Chinos
/
COVID-19
Tipo de estudio:
Diagnostic_studies
Idioma:
En
Revista:
Pharmazie
Año:
2022
Tipo del documento:
Article