The strategy outlines the European Medicines Agency’s (EMA) plan for advancing regulatory science over the next five years.
The strategy covers both human and veterinary medicines. The acceleration of innovation in recent years requires regulators to be prepared to support the development of complex medicines which utilise various technologies and processes. They must keep up with the rapidly changing society, instigated by advancements in science, technology and information handling.
The EU network must have access to the most up-to-date scientific data, methodologies and tools available, so the most appropriate decisions can be made. Expanded collaboration with stakeholders at every level is key to ensuring that patients and caregivers have the medicines and information necessary to make decisions about their use.
The five key goals of the strategy include:
- catalysing the integration of science and technology in medicines development;
- driving collaborative evidence generation – improving the scientific quality of evaluations;
- advancing patient-centred access to medicines in partnership with healthcare systems;
- addressing emerging health threats and availability/therapeutic challenges;
- enabling and leveraging research and innovation in regulatory science.
The recommendations and actions outlined in this strategy aim to ensure that regulators can advance public health and provide optimal medicines regulation in the coming years.
The EMA’s Executive Director commented on the strategy, “I am confident that it will enable us to take a leadership position on new developments, identify the gaps between science and healthcare systems and bring together the various stakeholders needed to bridge those gaps.”
Click here to access the EMA’s full strategy document.