Asian Journal Of Social Pharmacy

Abstract: Objective To analyze the application of real-world evidence (RWE) in the field of medicine in European Union, and provide suggestions for RWE supporting the review and approval of new drugs in China. Methods The European Medicines Agency (EMA) and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE. Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun. The decision-making process includes three stages such as new drug research and development, review, and approval. However, there are some challenges in data quality, research methods, evidence sufficiency, and research process of RWE supporting the European Union in reviewing and approving new drugs. At present, RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs. At the same time, RWE also can promote the development and application of Traditional Chinese Medicine (TCM) and help find out the potential value of TCM such as new indications.

Key words: real-world evidence, new drug review and approval, European Union, enlightenment