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RWE 201 | A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU

RWR CONTEXT

The European Union (EU) is making significant strides in advancing healthcare through a series of interconnected initiatives. The EU4Health Program aims to bolster health systems, focusing on crisis preparedness and disease prevention. The European Health Data Space is an effort to ensure secure access and exchange of health data across EU countries, enhancing healthcare quality and research. Complementing this, the Data Governance Act seeks to foster trust and facilitate data sharing for societal benefits. The European Medicines Agency (EMA)’s 2025 Vision for Real World Evidence (RWE) and the EMA RWE Framework to Support Regulatory Decision Making are pivotal in integrating real-world data (RWD) and RWE into regulatory processes, improving drug development and monitoring. The EU’s Action Plan for RWD & RWE further emphasizes the use of real-world healthcare data in policy and decision-making. Finally, the incorporation of RWD/RWE into the new EU Medicines Regulations marks a significant shift towards evidence-based, data-driven approaches in the pharmaceutical sector, aiming to enhance patient outcomes and healthcare efficiency across the EU.

OCTOBER 2023 – 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.

Our RWE 201 posts can be accessed here: https://rwr-regs.com/rwe-201/ 

The European Union (EU) is making significant strides in advancing healthcare through a series of interconnected initiatives. The EU4Health Program aims to bolster health systems, focusing on crisis preparedness and disease prevention. The European Health Data Space is an effort to ensure secure access and exchange of health data across EU countries, enhancing healthcare quality and research. Complementing this, the Data Governance Act seeks to foster trust and facilitate data sharing for societal benefits. The European Medicines Agency (EMA)’s 2025 Vision for Real World Evidence (RWE) and the EMA RWE Framework to Support Regulatory Decision Making are pivotal in integrating real-world data (RWD) and RWE into regulatory processes, improving drug development and monitoring. The EU’s Action Plan for RWD & RWE further emphasizes the use of real-world healthcare data in policy and decision-making. Finally, the incorporation of RWD/RWE into the new EU Medicines Regulations marks a significant shift towards evidence-based, data-driven approaches in the pharmaceutical sector, aiming to enhance patient outcomes and healthcare efficiency across the EU.

The following posts provide more details and visual summaries:

  • EU – EU4Health Program [Link]
  • EU – The European Health Data Space [Link]
  • EU – The Data Governance Act [Link]
  • EU – EMA’s 2025 Vision for RWE [Link]
  • EU – EMA RWE Framework to Support Regulatory Decision Making [Link]
  • EU – EU’s Action Plan for Real-World Data (RWD) & RWE [Link]
  • EU – RWD/RWE is Embedded into the New EU Medicines Regulations [Link]
RWE 201 | A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU2023-12-04T15:35:56+00:00

EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation

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EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation2023-11-05T11:05:33+00:00

EU | Mapping the Landscape of Data Intermediaries in the Context of the Data Governance Act

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EU | Mapping the Landscape of Data Intermediaries in the Context of the Data Governance Act2023-10-06T11:27:20+00:00

GERMANY | AKEK Statement on the Secondary Use of Patient Data for Research Purposes in Germany

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GERMANY | AKEK Statement on the Secondary Use of Patient Data for Research Purposes in Germany2023-09-05T11:35:29+00:00

ITALY | Ethical and Regulatory Issues in the Processing of Personal Health Data in Observational Research

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ITALY | Ethical and Regulatory Issues in the Processing of Personal Health Data in Observational Research2023-05-27T11:35:37+00:00
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