Asian Journal Of Social Pharmacy

Abstract:

Objective To provide references and suggestions for the application of real-world evidence in the decision-making of drug regulation in China. Methods The application of EU real-world evidence in drug regulatory decision support was analyzed through literature research and other methods, and the specific operation of its application was demonstrated by case studies. Results and Conclusion The application of EU real-world evidence in drug regulatory decision-making has achieved certain results and is in a stable development stage. The application of real-world evidence in China’s drug regulation is feasible. The successful application of EU real-world evidence can provide reference for China.

Key words:

EU, real-world evidence, drug regulatory decisions, enlightenment