The EMA is ready to address the challenges ahead, according to the agency’s incoming executive director Professor Guido Rasi, who has outlined his vision for the next five years.
Support for innovative medicines, a focus on transparency and greater patient involvement will be among the EMA’s priorities, said Rasi. He pointed to the challenges ahead, including shifts in medicines development through the vast progress made in the understanding of the human body and underlying science, and the increased globalisation of medicines development, as well as challenges stemming from the current pressure on healthcare systems.
He said: “I am confident that EMA, working closely with the national competent authorities in Member States, is ready to successfully address these new challenges.”
Professor Rasi highlighted five building blocks on which EMA’s response to these shifts would be built:
Focusing on research and development for medicines that address public health needs
Commitment to transparency, as 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,” he said
Best use of all available evidence, including a focus on the “impact of medicines in real life”
Global reference authority for the regulation of medicines; with development and manufacturing of medicines now global, regulatory authorities cannot work in isolation, he said. “We are reinforcing our role as a global reference authority, to provide the regulatory oversight that our citizens expect.”
Rasi also noted the importance of strengthening cooperation between Member States, the European Commission and other European and international partners, as well as involving communities and stakeholders for a more holistic approach to medicines evaluation and surveillance across the whole lifespan of a medicine.
Guido Rasi took office as EMA executive director on 16 November with a five-year mandate.