Ema started on December the open consultations on Regulatory Science strategy to 2025. “This document aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said Guido Rasi, EMA’s Executive Director. “The strategy includes developments and challenges in medicines development that we together with the Commission and NCAs experts have identified in a thorough process of mapping and selection. Now we want to hear from our stakeholders whether they consider this strategy is ambitious enough”.

Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.

The chapters of this guide include:

Human medicines – five strategic goals for regulatory science

“To underpin its mission of protecting human health, EMA must catalyse and enable
regulatory science and innovation to be translated into patient access to medicines
in evolving healthcare systems.”

  1. Catalysing the integration of science and technology in medicines development
  2. Driving collaborative evidence generation – improving the scientific quality of
    evaluations
  3. Advancing patient-centred access to medicines in partnership with
    healthcare systems
  4. Addressing emerging health threats and availability/therapeutic challenges
  5. Enabling and leveraging research and innovation in regulatory science

Veterinary medicines – four strategic goals for regulatory science

“To foster scientific excellence in the regulation of veterinary medicines for the benefit
of animal and public health while facilitating and promoting innovation and access to
novel medicinal products.”

  1. Catalysing the integration of science and technology in medicines development
  2. Driving collaborative evidence generation – improving the scientific quality
    of evaluations
  3. Addressing emerging health threats and availability/therapeutic challenges
  4. Enabling and leveraging research and innovation in regulatory science

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