Real-World Data and Regulatory Science is a peer-reviewed, international and interdisciplinary research journal, committed to building an international academic platform where real-world data drive regulatory decision-making. It systematically explores how real-world data and real-world evidence can be translated into actionable pathways across the entire healthcare life cycle and regulatory processes, while continuously advancing innovative tools, technical standards, and methodologies in regulatory science.

The scope includes, but is not limited to:

• Research on global policy and regulatory frameworks governing the application of real-world data in healthcare and regulatory decision-making throughout the full life cycle of medical products;

• Innovative clinical trial designs and statistical methodologies;

• Application of cutting-edge technologies such as artificial intelligence in data circulation, clinical research, and regulatory science;

• Institutional innovation and practices for healthcare data governance, circulation, and utilization;

• Legal and ethical issues in the application of healthcare data;

• Application of real-world data in early-phase clinical research;

• Application of real-world data in regulatory decision-making;

• Application of real-world data in health insurance claims;

• Application of real-world data in optimizing clinical diagnosis and treatment and precision medicine;

• Application of real-world data in regulatory decision-making and clinical evaluation of advanced therapy medicinal products (ATMPs).