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EPF responds to public consultation on EMA strategy

At the end of June, EPF submitted a response to the European Medicines Agency’s consultation on its strategic priorities for the next years, ”Regulatory Science to 2025”.

Regulatory science means “the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicines, that inform regulatory decision-making throughout the lifecycle of a medicine”. It encompasses basic and applied biomedical and social sciences, and contributes to the development of regulatory standards and tools. The draft strategy will help shape the next EU Medicines Agencies Network Strategy, 2020–2025.

Our response was broadly welcoming of the draft startegic goals. However, we pointed out that pharmacovigilace was not sufficiently described. Further improving the system for medicines safety monitoring and the reporting of side effects, including by patients, should be a key goal and action area, as it is crucial for patient safety and public health. 

Unfortunately the EMA’s strategy also lacked explicit mentions of meaningful, structured and systematic involvement of patients in each of the strategic goals. This in itself does not invalidate the goals, but is a EPF’s view a missing element that needs to be incorporated. Our response also makes proposals for the specific strategic goals.

The EPF response, submitted via online questionnaire, will be published by the EMA. In the meantime you can read it here.