The European Medicines Agency (EMA) published its Regulatory Science Strategy to 2025


On 31 March, the European Medicines Agency (EMA) published its Regulatory Science Strategy to 2025. The new RSS sets out the EMA’s strategic thinking for the advancement of regulatory science over the next five years, incorporating human as well as veterinary medicines.

The overall aim of this document is to identify the actions regulators can take to advance public health and ensure optimal pharmaceutical regulations in the coming years.

To this end, the RSS identifies 5 key goals:

  1. catalysing the integration of science and technology in medicines development;
  2. driving collaborative evidence generation;
  3. advancing patient-centred access to medicines;
  4. addressing emerging health threats and availability/therapeutic challenges;
  5. enabling and leveraging research and innovation in regulatory science;

Under each of the following goals, the EMA lists a set of core recommendations and corresponding supporting actions.

It is interesting to see that EMA has issued specific recommendations to optimise the capabilities in modelling, simulation and extrapolation through 7 concrete actions. This is a major development compared to the draft RSS published by the EMA in December 2018 which only underlined 3 actions with regards to the optimisation of capabilities in CM&S!

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