Pursuing Opportunities for Harmonisation in Using Real-World Data to Generate Real-World Evidence

This Reflection Paper was endorsed by the Assembly in June 2024.

The ICH Reflection Paper on “Pursuing Opportunities for Harmonisation in Using Real-World Data to Generate Real-World Evidence, with a focus on Effectiveness of Medicines”, presenting opportunities for development of new ICH Guidelines, was revised further to comments received during the public consultation held from June to September 2023.

Harmonised

E23 – Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines

In Process

E23 – Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines

Pre-harmonisation

E23 – Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines

Harmonised

M14 – General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

In Process

M14 – General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

Pre-harmonisation

M14 – General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

Pursuing Opportunities for Harmonisation in Using Real-World Data to Generate Real-World Evidence

Documents

Related guidelines

E23 – Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines

E23 – Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines

E23 – Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines

M14 – General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

M14 – General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

M14 – General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines