EMA Consults on Regulatory Science Strategy to 2025
Posted 19 December 2018 | By
The European Medicines Agency (EMA) on Wednesday launched a six-month public consultation on its proposed strategy for regulatory science through 2025 following two recent multi-stakeholder workshops
on the topic.
“The regulatory science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said EMA Executive Director Guido Rasi, adding that the agency developed the plan with input from the European Commission and experts from national regulatory authorities.
Rasi also says that a forward-looking strategy for advancing regulatory science is necessary “to support the development of increasingly complex medicines.”
EMA says it has five goals it intends to achieve by implementing the strategy:
- “Catalysing the integration of science and technology in medicine development;
- Driving collaborative evidence generation – improving the scientific quality of evaluations;
- Advancing patient-centered access to medicines in partnership with healthcare systems (for human medicines only);
- Addressing emerging health threats;
- Enabling and leveraging research and innovation in regulatory science.”
Within the 60-page document, EMA lays out its plans to address those goals for both human and veterinary medicines, breaking each goal up into various sub-goals and actions.
Some of the issues addressed in the wide-ranging plan include supporting the development of precision medicine and advanced therapy medicinal products (ATMPs); fleshing out the agency’s priority medicines (PRIME) scheme; facilitating advanced manufacturing; and advancing the agency’s understanding and regulation of nanotechnologies and other new materials.
The agency also says it wants to modernize evidence generation by further leveraging nonclinical models that can reduce the need for animal studies; promote innovative clinical trial designs; and improve modeling, simulation and extrapolation techniques.
Additionally, the strategy emphasizes the importance of international collaboration through partnerships with global regulators and international harmonization bodies, which EMA says it plans to continue to develop.
For the public consultation, EMA says it is looking for both general and specific comments on the strategic recommendations and goals outlined in the document from a wide range of stakeholders.
Specifically, EMA says it wants to know whether the goals it has set are appropriate; if the actions detailed to achieve them are adequate; and whether any important elements are missing from the strategy.
, Regulatory Science to 2025: Strategic Reflection