Optimizing Patient Registries for Regulatory Decision Making - Key Learnings From an HMA/EMA Multistakeholder...

Area of Science:

• Regulatory Science
• Health Informatics
• Pharmacovigilance

Background:

• The Joint Heads of Medicines Agencies and European Medicines Agency's (HMA/EMA) initiative aims to integrate real-world data into regulatory decisions.
• Patient registries are a key source of real-world data with significant potential for regulatory use.

Purpose of the Study:

• To explore optimization of the EMA qualification procedure for patient registries.
• To establish the value and enable the use of patient registry data for diverse research questions.
• To enhance regulatory decision-making through improved real-world data integration.

Main Methods:

• A two-day multistakeholder workshop organized by the EMA in 2024.
• Analysis of recommendations for optimizing registry qualification and data utilization.
• Review of procedural steps and stakeholder interactions.

Main Results:

• Key recommendations include clarifying the aim, scope, and added value of registry qualification.
• Procedural steps need review to ensure fitness-for-purpose in regulatory contexts.
• Strengthening stakeholder interactions and support through awareness of tools and guidance is crucial.

Conclusions:

• The European Medicines Regulatory Network is implementing actions based on workshop recommendations.
• Updates to guidance, development of templates, and enhanced communication plans will improve patient registry data use.
• Optimal use of patient registry data will support public health in the European Union.