ABSTRACT
Objective:To review the historical evolution and current situation of approval system for marketing application of new chemical pharmaceuticals in China to provide reference for the establishment of more perfect approval system. Methods: Through clearing up the historical evolution of approval regulations for marketing application and combining with the current approval system,the development track of the regulatory system from the vulgar administration gradually transferring to the scientific management was ana-lyzed comprehensively. Results and Conclusion: The dividend of current approval system has appeared, meanwhile, the constantly improving process will lay the foundation for setting up the regulatory system conforming to the situation of China and in line with inter-national standards.