The experienced prescriptions of famous prestigious Chinese physicians are effective prescriptions developed by prestigious Chinese doctors during their long-time clinical practice

which reflect the traditional Chinese medicine (TCM) understanding of the disease development regularity and core pathogenesis. These experienced prescriptions provide valuable experience for medication and prescription regularities

and represent the highest level of TCM treatment and the major sources of new drug research

development and technology innovation. It is of great significance to inherit academic thoughts and clinical experiences of prestigious Chinese physicians

explore and summarize experienced prescriptions

and develop new Chinese drugs. The researches of new drugs based on experienced prescriptions are the major direction encouraged by the government

with the maximum amount of new TCM drug applications but a low approval rate in recent years. The main reason for the low number of approved new TCM drug applications is that researchers know less about evaluation concepts and relevant techniques

leading to problems in research and development strategy. To facilitate a smooth advance of the new drug research and development and take full advantage of the experienced prescriptions

in this paper

we focus on the problems about new drug development of experienced prescriptions

lay emphasis on the new TCM drug research and development concepts of clinical value

history of human application and whole-process quality control

and deeply and systematically analyze concerns in such links as pharmacy

pharmacodynamics

toxicology and clinic application. The purpose of this article is to provide the reference in solving actual problems

the reliable basis of further researches on experienced prescriptions

and the important guarantee for developing more safe

effective and high-quality controllable drugs to meets clinical requirements

so as to achieve the strategy of a healthy China.