Rasi Spells Out EMA’s Top 5 Priorities

Patient involvement, transparency, and support for innovative medicines are among the key objectives of the European Medicines Agency (EMA) over the next five years, according to Executive Director Prof. Guido Rasi.

At a press briefing December 9, Rasi highlighted the Agency’s five most urgent priories:

• Focus on research & development for medicines that address public health needs and have the potential to improve patients' lives so that innovation translates into public health benefits.

• Maintain transparency. For instance, EMA claims to be the first global regulator to allow researchers, academics, and the public access to the clinical data on which marketing authorizations are based.

• Increase patient involvement in the EMA’s work by ensuring the views and needs of the public are taken into account.

• Make use of all available evidence. Integrating all available data enables real-time monitoring of the safety and efficacy of medicines.

• Act as a global reference authority for the regulation of medicines. Development and manufacturing of medicines is now global and regulatory authorities cannot work in isolation.

To address these challenges, Rasi noted the need 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.

"I am confident that EMA, working closely with the national competent authorities in Member States, is ready to successfully address these new challenges,"said Rasi, who took office on November 16, 2015, having been nominated as Executive Director for a five-year mandate by the Management Board of the Agency on October 1, 2015.