International Harmonization of Real World Evidence Standards Dashboard

Since 2018, the Duke-Margolis Institute for Health Policy’s Real-World Evidence (RWE) Collaborative has convened stakeholders representing medical product developers, data companies, payers, research groups, providers, patient networks, as well as experts on regulatory affairs, law, health and data science, and policy, with a shared goal and interest to advance RWE policy. This effort includes convening stakeholders who hold shared goals to advance RWE policy among international agencies, health technology assessment bodies, and regulators. With ongoing support from our RWE Collaborative members, the Duke-Margolis RWE policy research team developed the International Harmonization of Real World Evidence Standards Dashboard with the primary goal of helping internationally-focused RWE policy stakeholders track, in one place, relevant and timely regulatory guidance, frameworks, international harmonization documents, and more.

Share your suggestions or potential updates for the Dashboard by contacting Maryam Nafie or Valerie Parker.

To learn more about the Duke-Margolis RWE Collaborative and RWE research portfolio, contact Dr. Rachele Hendricks-Sturrup.

We would like to acknowledge Eric Monson, Ph.D., within the Duke University Libraries’ Center for Data and Visualization Sciences for advising and assisting our project team in the development of this Dashboard.

Hover over the three icons at the bottom right to share a link to the Dashboard, download it, or view it in full-screen mode.

The documents listed below are non-guidance documents from regulatory agencies that include RWE related strategy documents, reports and frameworks.

Global:

• ICMRA Statement on international collaboration to enable real-world evidence (RWE) for regulatory decision-making
• ICH Reflection Paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines
• CIOMS Working Group (draft) Report: Real-world data and real-world evidence in regulatory decision-making
• ISPOR, ISPE, the Duke-Margolis Center for Health Policy and the National Pharmaceutical Council Real-World Evidence Transparency Initiative
• Establishment of a new ICH guideline on “General principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines"
• Theraputic Goods Administration (TGA) Adoption of International Scientific Regulatory Guidelines
• M-14 General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicine

Last updated: 8/5/2024

List of latest updates (in order from most recent to least):

• Added NMPA Definition for Data Quality and Fit-for purpose.
• EMA's Real-world evidence framework to support EU regulatory decision-making 2nd report on the experience gained with regulator-led studies from February 2023 to February 2024
• FDA's Final Guidance on "Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products"
• Definitions of RWE
• Original untranslated MFDS Guidance Documents: Guideline for Medical Information Database Research, Guideline on Risk Management Plan for Medicines to allow post-marketing safety study based on database study using RWD and Guideline on RWE for Medical Devices
• New Summary statement on the top right corner of the "Number of RWE Guidance Documents and Frameworks Across Regulatory Agencies" visualization
• New translated TFDA document "Final Guidance on Requirements When Using Real World Data/Real World Evidence as Drug Review Documents"
• Link to TGA webpage describing the adoption of international regulatory guidelines
• New Draft ICH M-14 guideline