Asian Journal Of Social Pharmacy

Abstract: Objective To analyze the value of EU real-world evidence (RWE) in supporting the expanded indications for drugs and to provide reference for the decision-making of expanding drug indications supported by RWE in China. Methods By searching relevant domestic and foreign literature and case analysis, the practice of the RWE of EU to support the expansion indications for drugs was investigated. Results and Conclusion The EU uses RWE to
carry out adaptive path research, which provides a new idea for drug R&D and approval. Besides, it also provides evidence in supporting the research of expanded indications for drugs. With the increasing cognition of RWE, it will play a key role in medical and regulatory decisions in China.

Key words: EU, real-world evidence, expanded indication, adaptive path, enlightenment