Returning Rasi Outlines 5-Year Vision for EMA

At his first press briefing since his re-instatement as Executive Director of the European Medicines Agency on November 16, 2015, Guido Rasi yesterday outlined his vision for his five-year mandate.   Professor Rasi began the meeting by saying the period of "transition" he experienced this year had given him time to reflect on how EMA is to address the progress made in the understanding of the human body and the underlying science, the increased globalization of medicines development and manufacturing, and the current pressure on healthcare systems.   He highlighted five "building blocks" on which EMA's response to these shifts will be strengthened:
  • A focus on R&D 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."
  • A 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 authorizations 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."