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EMA sets out new five-year plan

Published on 09/12/15 at 04:57pm
Guido Rasi
Guido Rasi

The European Medicines Agency’s (EMA) new executive director, Professor Guido Rasi, outlined his vision for his five-year mandate at the helm of the Agency, at a press briefing today, highlighting five building blocks as a response to the shifting drug development landscape.

Rasi highlighted the vast progress made in the understanding of the human body and the underlying science, the increased globalisation of medicines development and manufacturing, as well as the current and rising pressure on healthcare systems.

The executive director, who has held the post in his second term since last month, noted the accelerating rate of medicines approved, which reached 84 this year, and the fact that 85% of medicines in the EU have at least one step of their production process happening outside of Europe.

Rasi said: “As regulators, we need new approaches for a new era and we must steer research and development towards areas of unmet need,” and pointed to the PRIME initiative as a way of providing support in these efforts.

Rasi also spoke of the need to expedite the approval process in a manner that maintains the quality of products and does not compromise patient safety.

He said: “We will encourage development of a model enabling reduced cost, to shorten the time to market authorisation without reducing standards.” Rasi did however warn that the timescale to implement such changes to the approvals process could be a matter of several years.

The five building blocks Professor Rasi highlighted to ensure the EMA's effective response to these shifts were:

  • Focusing on research & development for medicines that address public health needs: "We want to focus our efforts on those medicines which have the potential to really improve patients' lives – so that innovation clearly translates into public health benefits."
  • Commitment to transparency: "We have a pioneering approach to transparency. We are the first regulator in the world to allow researchers and academics, and the public as a whole, access to the clinical data on which marketing authorisations are based."
  • Patient involvement: "All that we do must ultimately benefit patients. This is why we involve them more and more in our work, to ensure their views and needs are taken into account at every step of the process."
  • Best use of all available evidence: "In Europe, with a population of over 500 million citizens, the opportunities to study the impact of medicines in real life and monitor their safety and efficacy are enormous. Integrating all available data enables real-time monitoring of the safety and efficacy of medicines."
  • Global reference authority for the regulation of medicines: "Development and manufacturing of medicines is now global and regulatory authorities cannot work in isolation. We are reinforcing our role as a global reference authority, to provide the regulatory oversight that our citizens expect."

In addressing these challenges, Professor Rasi noted the importance of strengthening co-operation with Member States, the European Commission and other European and international partners, and of bringing communities and stakeholders involved closer together to enable a more holistic approach to medicines evaluation and surveillance across the whole lifespan of a medicine, from development to patient use.

"I am confident that EMA, working closely with the national competent authorities in Member States, is ready to successfully address these new challenges,” he added.

Joel Levy

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