European Medicines Agency [to 25 June 2016]
http://www.ema.europa.eu/

.
24/06/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016
Six new medicines, including one cell-based therapy, recommended for approval ..

.
22/06/2016
EMA and FDA reinforce collaboration on patient engagement
New working group established to exchange best practices
The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on patient engagement. The cluster will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorisation activities related to medicines.

Patients bring real-life experience, as well as specific knowledge and expertise, to scientific discussions on medicines and on the impact of regulatory decisions. Therefore, their involvement is a priority for both agencies.

“Our aim as regulators is to make sure that patients have access to safe and effective medicines that improve their lives. It is important to engage to be able to fully understand their needs and priorities and make their voice heard along a medicine’s lifecycle,” explains Guido Rasi, EMA Executive Director. “Many of the challenges and benefits of working with patients are similar for both regulators. We look forward to increasing our collaboration with FDA in this area in order to benefit from each other’s experiences, and to advance patient involvement.”

The first meeting of the cluster took place by teleconference on 22 June 2016…