Abstract: Objective To introduce the concept, characteristics and functions of relevant terms such as real-world evidence, expounded the opportunities and challenges of real-world evidence in drug regulation and health decision-making, and put forward some suggestions for realizing the life cycle monitoring of pharmaceutical products, so as to further strengthen the scientific nature of decision-making. Methods Based on comprehensive literature search at home and abroad, this paper studied the real-world study and its’ appliance in the development of drug safety, effectiveness and economic decision-making; summarized the present situation of China's development in this area; made the analysis of the opportunities and challenges of real world evidence. Results and Conclusion Real-world evidence can provide strong support for product lifecycle evaluation in decision-making. Developed countries such as Europe and the United States are currently conducting extensive application research and legislation in this area, while China has been still in the start stage. Therefore, more efforts should be made to further develop RWE in its value exploration and application range expanding, and further promote the establishment of proactive regulatory model of regulatory authorities.

Key words: real-world evidence, real-world research, health decision-making