Real World Evidence (RWE) 201

A Landscape Analysis of Regional RWE Frameworks

Real World Evidence (RWE) 201 – Germany’s Draft Health Data Usage Act

December 8, 2023|2023, RWE 201|

RWE 201 - Germany's Draft Health Data Usage Act   Draft Health Data Usage Act (GDNG): https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/detail/gesundheitsdatennutzungsgesetz.html BfArM Health Research Data Center: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Forschungsdatenzentrum/_node.html In June 2023, the [...]

RWE 201 Topics

In our real world evidence (RWE) 201 series we have been exploring the regional regulatory and data access frameworks that have been implemented to support access to clinical experience data (real world data | RWD), which is crucial if we are to use this RWD to generate RWE.

  • USA – The 21st Century Cures Act (Cures 1.0) [Link] [LinkedIn]
  • USA – FDAs RWE Framework [Link] [LinkedIn]
  • USA – FDA’s RWE Considerations Draft Guidance [Link] [LinkedIn]
  • USA – A Tale of Two Regulatory Paths: Non-Interventional Studies in the USA [Link] [LinkedIn]
  • USA – FDA’s Advancing RWE Program [Link] [LinkedIn]
  • Canada – Beyond Clinical Trials: Health Canada’s Commitment to Real World Evidence [Link] [LinkedIn]
  • Canada – Health Canada’s 15 Key Elements for Protocol Development [Link] [LinkedIn]
  • Canada – Methods and Guidelines for Reporting Real World Evidence [Link] [LinkedIn]
  • Canada – Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making [Link] [LinkedIn]
  • France – Health Data Hub: Facilitating Access to Real World Data [Link] [LinkedIn]
  • France – CNIL Reference Methodologies: Facilitating Access to Real World Data [Link] [LinkedIn]
  • France – CNIL Regulatory Sandbox: Digital Health [Link] [LinkedIn]
  • France – Haute Autorité de Santé (HAS) – Real World Study Guide [Link] [LinkedIn]
  • UK – MHRA – Use of RWD to Support Regulatory Decisions [Link] [LinkedIn]
  • UK – MHRA – Randomised Controlled Trials Using Real World Data [Link] [LinkedIn]
  • UK – NICE – RWE Framework [Link] [LinkedIn]
  • UK – NHS England – Federated Data Platform – Lessons Learned from the General Practice Data for Planning and Research Initiative [Link] [LinkedIn]
  • Germany – AKEK – Secondary Use of Patient Data for Research Purposes [Link] [LinkedIn]
  • Italy – CCNCE – Ethical and Regulatory Issues in the Processing of Patient Data in Observational Research [Link] [LinkedIn]
  • Finland – Leaders in Integrating RWE into Healthcare, Policy, and Research [Link] [LinkedIn]
  • Sweden – Pioneering the Use of RWD [Link] [LinkedIn]
  • Norway – Real World Data Initiatives [Link] [LinkedIn]
  • NORWAIT – A Cautionary Tale [Link] [LinkedIn]
  • Denmark – A Hub for RWE Research [Link] [LinkedIn]
  • EU 2021 – Setting the Scene for the European Health Data Space [Link] [LinkedIn]
  • EU – EU4Health Program [Link] [LinkedIn]
  • EU – The European Health Data Space [Link] [LinkedIn]
  • EU – The Data Governance Act [Link] [LinkedIn]
  • EU – EMA’s 2025 Vision for RWE [Link] [LinkedIn]
  • EU – EMA RWE Framework to Support Regulatory Decision Making [Link] [LinkedIn]
  • EU – EU’s Action Plan for Real-World Data (RWD) & RWE [Link] [LinkedIn]
  • EU – RWD/RWE is Embedded into the New EU Medicines Regulations [Link] [LinkedIn]
  • Spain – Championing the Ethical and Responsible Use of Real World Data [Link] [LinkedIn]
  • RWE Guest Post – Germany – From Concept to Evaluation: The Journey of RWE requests by the G-BA [Link] [LinkedIn]
  • RWE Guest Post – Does Real-World Evidence Play a Role in G-BA’s Benefit Assessments in Germany? [Link] [LinkedIn]
  • Lithuania – Leaping into Digital Health Future with RWE and RWD Innovations [Link] [LinkedIn]
  • Latvia – Making Early Strides to Implement RWE and RWD Initiatives [Link] [LinkedIn]
  • Poland – The Journey towards Real World Evidence and Digital Transformation [Link] [LinkedIn]
  • Germany – Germany’s Draft Health Data Usage Act [Link] [LinkedIn]
  • EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation [Link] [LinkedIn]
  • China – China’s Emerging Trend: Embracing Real-World Evidence in Drug Development and Regulation [Link] [LinkedIn]
  • Japan – Revolutionizing Healthcare in Japan: The Rise of Real-World Evidence in Drug Development [Link] [LinkedIn]
  • Taiwan – Integrating Real-World Evidence for Drug Development and Policy Making [Link] [LinkedIn]
  • South Korea – South Korea’s Pioneering Approach: Integrating Real-World Evidence in Healthcare and Drug Development [Link] [LinkedIn]
  • Australia – Advancing Healthcare in Australia: Embracing Real-World Evidence and Data in Medicine Regulation and Development [Link] [LinkedIn]
  • RWE Event Horizon [Link] [LinkedIn]
  • THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU [Link] [LinkedIn]