Enlightenment of drug application and evaluation procedures of medicines registered (listed) in Australia on studies of new traditional Chinese medicines.
- Author:
Jian-Xun REN
;
Jian-Xun LIU
- Publication Type:Journal Article
- MeSH:
Australia;
Drug Approval;
Drug Evaluation;
Medicine, Chinese Traditional
- From:
China Journal of Chinese Materia Medica
2014;39(21):4265-4267
- CountryChina
- Language:Chinese
-
Abstract:
Modern and international studies on new traditional Chinese medicines are the main trend of the development of traditional Chinese medicines at present. In Australia, new traditional Chinese medicines refer to complementary medicines, which are mainly registered and launched as listed medicines. The application documents of registered (listed) medicines in Australia mainly cover detailed description of active pharmaceutical ingredients, pharmacological and toxicological studies, dosage form and adverse effects. Each part has detailed specifications and instructions, which helps ensure that applicants could accurately understand the requirements in application for registering (listing) medicines, and provides very important reference to the studies and development of new traditional Chinese medicines in China.
