Thoughts on current chemistry, manufacturing & control(CMC)technical review requirement of chemical active pharmaceutical ingredients

This article reviews drug research and evaluation history in China in the last decades, which analyses current status of Chinese pharmaceutical industry and changes of chemical active pharmaceutical ingredient evaluation principles and technical requirement from Center for Drug Evaluation(CDE)of China Food and Drug Administration(CFDA). Key points during the research and development of active pharmaceutical ingredient are detailed analyzed in connection with the current drug evaluation status and issues should be paid attention during the drug research and development are introduced from synthesis process, control of starting material and intermediate, key steps and processing parameters, crystal form, batch, structural identification, research of quality, quality standard and stability and other perspectives. This article can be considered by persons for drug research and development in China.