Dissection of differences and similarities of botanical drugs in European Union, US and Canada / 中国中药杂志
China Journal of Chinese Materia Medica
;
(24): 2747-2750, 2011.
Artículo
en Chino
| WPRIM
| ID: wpr-293228
ABSTRACT
Because of the unique nature and treatment concept of traditional Chinese medicines (TCMs), TCMs have been respected again since 70s of last century. The regulatory agencies of some developed countries (the FDA, EMA and Health Canada etc) have published new guidance/guidelines/directives in recent years, such as the botanical drug product guidance of the FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products/ traditional herbal medicinal products of the EMA etc. All of the regulatory agencies are willing to scientifically evaluate the herbal medicines and accept it as therapeutic product. This paper analyzed the history of herbal medicine regulation and the similarities and differences of the regulatory requirements of the European Union, the United States and Canada, proposed possible future direction of the international development of Chinese medicine from the perspective of global regulatory affairs.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Plantas Medicinales
/
Estándares de Referencia
/
Estados Unidos
/
Canadá
/
Química
/
Medicina de Hierbas
/
Historia del Siglo XX
/
Historia del Siglo XXI
/
Control de Medicamentos y Narcóticos
/
Unión Europea
Tipo de estudio:
Guía de Práctica Clínica
Límite:
Humanos
País/Región como asunto:
America del Norte
Idioma:
Chino
Revista:
China Journal of Chinese Materia Medica
Año:
2011
Tipo del documento:
Artículo
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