Feasibility Assessment and Governance of Real-World Data in China
Recently, the Guidelines for Real-world Data Used in the Generation of Real-world Evidence (referred to below as the Guidelines) issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) were offered to the public for comments [1]. The Guidelines comprehensively elaborate the definitions, sources, evaluations, governance, standards, safety compliance, quality assurance, applicability, and other aspects of real-world data (RWD), to provide specific requirements and guiding recommendations for RWD. They provide a guidance on how RWD can be used to generate real-world evidence (RWE) to support drug development and how feasibility assessment and data governance should be done.