EMA publishes report on mid-term regulatory science strategy

Progress in supporting the development of precision medicine was noted as an achievement in a mid-term report on EMA’s Regulatory Science Strategy to 2025.

The European Medicines Agency (EMA) has published a report summarizing the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. Originally published in March 2020, the strategy provides a blueprint for advancing regulatory science over a period of five years.

Regulatory science refers to the scientific disciplines that are applied to the evaluation of the quality, safety and efficacy of drugs. These contribute to the development of standards and regulatory tools, according to the EMA.

Implement EMA’s regulatory science strategy until 2025

Included are achievements for the top five human recommendations considered to bring the most significant change during the five-year strategy. This is in line with the stakeholder consultation process that took place with EMA scientific committees, stakeholders and EU regulatory partners.

Progress has been observed in several areas, including:

Foster innovation in clinical trials Promote the use of real, high-quality data in decision-making Contribute to the preparation of health technology assessment (HTA) bodies and downstream decision-making for innovative medicines Support developments in precision medicine.

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

The regulator noted that the strategy was driven by recognition of the accelerated pace of innovation in recent years. Thus, regulators had to be prepared to support the development and evaluation of ever more complex drugs that offer more and more healthcare solutions by converging different technologies.

The pressures that have affected the industry during the COVID-19 pandemic have proven the need for rapid and close engagement of stakeholders and partners involved in drug development. This need was one of the fundamental principles of this strategy, specifies the EMA.

“We will seek opportunities to advance the implementation of the Regulatory Science Strategy to 2025 and the broader 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 network’s ability to engage and enable science and technology innovation within the current pharmaceutical framework and pave the way for legislative review,” Cooke added.

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

Related Topics

Big Pharma, Biopharmaceutical, Clinical Development, Drug Development, Drug Manufacturing, Drug Supply Chain, Industry Overview, Manufacturing, Regulation and Legislation, Research and Development (R&D), Technology, Therapeutics

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