Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations

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Limited effectiveness of risk minimisation strategies was observed, highlighting the need for improved methods.
About 50% of studies achieved all objectives, while the remaining had limitations or were inconclusive.
Thematic analysis was used to draw insights from the evaluations conducted between 2015 and 2023 across EU member states, revealing valuable lessons for decision-making processes in regulation of medicines. Regulatory interventions must address effectiveness measurements to enhance future impact studies.

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Lessons learnt analysis of regulatory interventions reveals varying effectiveness in risk minimisation, suggesting improvements for future studies.

Goedecke et al. (2024) studied this question.

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Lessons learnt analysis of regulatory interventions reveals varying effectiveness in risk minimisation, suggesting improvements for future studies.