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Ramulus Mori (Sangzhi) alkaloids tablets for diabetes mellitus: A regulatory perspective - ScienceDirect
Source: sciencedirect.com
Article summary:
1. The reform of the review and approval system for Traditional Chinese Medicine (TCM) has introduced a new registration classification and established a review and approval evidence system.
2. Ramulus Mori (Sangzhi) alkaloids Tablets are a brand new drug, and a new model of TCM review and approval evidence system has been developed through contemporary research.
3. This paper discusses the registration process of new Chinese medicine drugs under the “three integrated review and approval system”, retraces the development process of Mulberry alkaloid tablets, and discusses opportunities and challenges encountered under the “three integrated” evidence system.
Article analysis:
The article is generally reliable in terms of its content, as it provides an overview of the current state of Traditional Chinese Medicine (TCM) review and approval systems, as well as discussing the development process of Ramulus Mori (Sangzhi) alkaloids Tablets. The article also provides some insight into potential challenges that may be encountered when developing botanical drugs in general. However, there are some potential biases that should be noted. For example, the article does not provide any counterarguments or explore any possible risks associated with using this type of drug for diabetes mellitus treatment. Additionally, there is no mention of other types of treatments that may be available for diabetes mellitus patients, which could lead to a one-sided reporting on this topic. Furthermore, there is no discussion on how this type of drug may interact with other medications or treatments that diabetes mellitus patients may already be taking or undergoing. In conclusion, while this article provides an informative overview on TCM review and approval systems and Ramulus Mori (Sangzhi) alkaloids Tablets development process, it should be read with caution due to potential biases mentioned above.