The supervision of research and development of new Chinese medicine drugs has become stricter
On January 7, the State Food and Drug Administration issued five consecutive guiding principles, including innovative drugs, improved new drugs, traditional Chinese medicines, and clinical trials.
Among them, the "Technical Guidelines for The Bioavailability and Bioequivalence of Innovative Drugs" proposes that drugs may change in terms of APIs, preparations and drug delivery schemes, which may have an impact on safety and efficacy. Therefore, bioavailability (BA) and bioequivalence (BE) will become necessary research projects.
These studies become "mandatory" and will open up new opportunities for businesses offering relevant CRO services.
In addition to innovative drugs, chinese medicines that have recently triggered a wave of ups and downs are also in the guiding principles of this release.
According to the "Technical Guidelines for Sample Research for Toxicology research of New Chinese Medicines (Trial)" released this time, there are many unknown components in Chinese medicines, and the State Food and Drug Administration has provided regulations and guidance for sample preparation, quality control and preparation of new Chinese medicine toxicology research.
This means that the research and development of new Chinese medicine drugs will also be subject to stricter supervision.
Just seven days after 2022, the State Food and Drug Administration has issued 17 guiding principle documents. At a time when the market environment for innovative drugs is becoming more and more severe, the Food and Drug Administration is also gradually promoting the transparency and scientificization of the domestic pharmaceutical environment.
Text | niacinamide
Operational | Yan Ning
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