关键词: font-size:medium, ">中美欧；附条件批准；监管要求；药品审评制度

Abstract: The "conditional approval of drug listing"system is a drug review system introduced in China newly revised "Drug Administration Law of the People′s Republic of China", "Drug Registration Management Measures" and other regulations，with a view to improving my country′s drug registration review mechanism in China, encourage clinical value-oriented drug innovation, accelerate the listing of clinically urgently needed drugs with outstanding clinical value, and shorten the time for clinical application of new technologies. However, due to the short time for the establishment of this system in China, the legal system is still being improved, and social understanding is also different. In order to give full play to the positive role of the "conditional approval of drug listing" system in promoting the research and development of new drugs and ensuring the clinical benefits/risk prevention and control of new technologies.This study sorts out the drug conditional approval process in China, US, and EU, mainly based on regulatory requirements, technical connotations and risk control. It is hoped that all sectors of the society will have a comprehensive understanding of the conditional approval and marketing system of drugs, and to provide references for applicants and drug regulatory agencies to use the conditional approval properly in practice.
   

Key words: China, US and EU； Conditional approval process； Regulatory requirements； Drug review system