ICH reflection paper to further enable real-world evidence integration into regulatory decisions

In June 2024, following a 3-month public consultation, the Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly adopted a reflection paper called “Pursuing Opportunities for Harmonization in Using Real-World Data to Generate Real-World Evidence, with a focus on Effectiveness of Medicines”.  The aim of this paper is to harmonise real-world evidence terminology and establish general principles for the planning and reporting of studies using real-world data to support regulatory decision-making worldwide.

The paper was co-developed by EMA, FDA and Health Canada following a joint statement by ICMRA calling for international collaboration in generating and using real-word evidence in regulatory decision making. This marks an important commitment from ICH towards harmonisation of regulatory real-world evidence guidance.

Acess the reflection paper here. 

Public consultation: ICH M14 draft guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines

The draft guideline provides internationally harmonised guidance, recommendations and best practices for the conduct of pharmacoepidemiological studies using real-world data for the assessment of the safety of medicines. The aim is to streamline the development and regulatory assessment of study protocols and reports and make them more acceptable to health authorities worldwide.

EMA is coordinating a European public consultation until 30 August 2024. It takes place in parallel to the global public consultation launched by ICH.

Access the open consultation here.