Executive Director Guido Rasi has outlined his vision for his five-year mandate at the helm of the European Medicines Agency (EMA).
Among the current shifts in medicines development, Professor Rasi said progress has been 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 pressure on healthcare systems.
'I am confident that EMA, working closely with the national competent authorities in Member States, is ready to successfully address these new challenges,' he said.
Rasi highlighted the five ways in which EMA will respond to these shifts.
First, EMA will focus 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,' explained Rasi.
Second, EMA has 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 authorisations are based,' Rasi said.
Third, EMA will ensure that patients are involved: '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.'
Fourth, EMA will make best use of all available evidence: 'In Europe, with a population of more than 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.'
Fifth, EMA aims to be the 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,' he said.
To address these challenges, Professor Rasi said it is important to strengthen cooperation with Member States, the European Commission and other European and international partners, and to bring communities and stakeholders involved closer together for a more holistic approach to medicines evaluation and surveillance across the whole lifespan of a medicine.
Rasi took office as Executive Director of EMA on 16 November 2015. He was nominated as Executive Director for a five-year mandate by the Management Board of the Agency on 1 October 2015.