EMA - Mid-point Report Published

27th March 2023

EMA

“The achievements highlighted in this report demonstrate that we have made considerable progress in advancing regulatory science to build a more adaptive regulatory system that encourages innovation in human and veterinary medicines,” said Emer Cooke, EMA’s Executive Director.

The mid-term report highlights achievements for the top five human and top three veterinary recommendations thought to deliver the most significant change over the course of the five-year strategy, according to an extensive stakeholder consultation process that took place with EMA’s scientific committees, stakeholders and EU regulatory partners.

In the human domain, progress was made in several areas, including:

• fostering innovation in clinical trials;
• promoting use of high-quality, real-world data in decision making;
• reinforcing patient relevance in evidence generation;
• contributing to health technology assessment bodies’ (HTA) preparedness and downstream decision making for innovative medicines;
• supporting developments in precision medicine, biomarkers and ‘omics.

In the veterinary domain, progress was made in several areas, including:

• transforming the regulatory framework for innovative veterinary medicines;
• developing new approaches to improve the benefit-risk assessment of veterinary medicinal products;
• collaborating with stakeholders to modernise veterinary pharmacoepidemiology and pharmacovigilance.

The report also highlights achievements for the human and veterinary medicines strategies. Links are included in the report to detailed information on goals, core recommendations and underlying actions in these areas.

Work will continue at pace through 2023-2025 to deliver the strategic goals to their fullest potential.

A final report on the regulatory science strategy will be published in 2026, once the strategy has been completed.

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