From clinical trials to precision medicine. From Ema a medium-term report 2020-2025 with the objectives achieved

In the human sector, progress is being made in several areas, including promoting the use of real, high-quality data in decision-making; strengthen patient relevance in the generation of evidence; contribute to the preparation of Health Technology Assessment (HTA) bodies and downstream decision-making for innovative medicines. In the veterinary sector, the development of new approaches to improve the assessment of the benefits and risks of veterinary medicines and transformation of the regulatory framework for innovative veterinary medicines. THE REPORT

22 MAR –

EMA published a report summarizing the interim results of its Regulatory Science Strategy (RSS) up to 2025. The report provides an overview of the main results achieved between March 2020 and December 2022 in the human and veterinary areas.

“The findings highlighted in this report demonstrate that we have made significant strides in advancing regulatory science to build a more adaptive regulatory system that encourages innovation in human and veterinary medicines,” he said. Emer CookeExecutive Director of EMA.

The interim report highlights the achievements for the five key recommendations in the human field and the three key recommendations in the veterinary field, considered to bring about the most significant changes during the five-year strategy, according to an extensive stakeholder consultation process that has involved EMA’s scientific committees, EU stakeholders and regulatory partners.

In the human sector, progress has been made in several areas, including:
– promote innovation in clinical trials;

– promote the use of high-quality, real data in decision-making;
– strengthen the relevance of the patient in the generation of evidence;
– contribute to the preparation of Health Technology Assessment (HTA) bodies and downstream decision-making for innovative medicines;
– support developments in precision medicine, biomarkers and omics.

In the veterinary sector, progress has been made in several areas, including:
– transformation of the regulatory framework for innovative veterinary medicines;
– the development of new approaches to improve the assessment of the benefits and risks of veterinary medicines;
– working with stakeholders to modernize veterinary pharmacoepidemiology and pharmacovigilance.
– The report also highlights the achievements of strategies for human and veterinary medicines.

Work will continue apace through 2023-2025 to deliver the strategic objectives to their full potential.

“We will look for opportunities to further advance the delivery of the Regulatory Science Strategy to 2025 and the wider European Medicines Agency Network Strategy to 2025, as we emerge from a long period of business continuity. This work will be crucial in evolving the capacity of the network to engage and enable innovative science and technology within the current pharmaceutical framework and lead the way for legislative review,” Cooke added.

A final report on the regulatory science strategy will be published in 2026, once the strategy is complete.

March 22, 2023
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