Asian Journal Of Social Pharmacy

Abstract: Objective To analyze the application of EU real-world evidence in the decision-making of new drug research and development (R&D), and to provide policy recommendations for China’s government to make new drug R&D decisions. Methods The relevant policy documents of the EU on the development of new drugs and other domestic and foreign literature on the real-world evidence were analyzed to obtain the role and application of the current EU real-world evidence in the implementation of new drug development policies. Results and Conclusion At present, the EU is carrying out the national synchronous scientific advisory policy, urging the formation of a European innovation framework, and providing decision-making for new drug R&D selection and program design based on real-world evidence. It is recommended that China build a real-world medical database and design a new drug screening platform to help companies, scientific research institutions assess target drugs. In addition, a national scientific advisory platform should be set up to integrate scientific research strength and provide technical support for new drug R&D institutions.

Key words:

EU, real-world evidence, R&D decision-making, R&D policy