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The two agencies have set up a working group on involving patients in drug development.
The European Medicines Agency (EMA) and FDA have set up a collaboration on patient engagement. The cluster (i.e., a series of regular meetings) will be a forum for the agencies to share experiences and best practices on involving patients in the development and evaluation of drugs.
Because patients bring real-life experience to scientific discussions, the agencies are making their involvement a priority. The cluster will allow for the exchange of information between the agencies. The cluster discussions will focus on the processes for selecting and preparing patients for involvement, ensuring that patients are independent, and reporting the impact of patient involvement.
“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,” explained Guido Rasi, EMA executive director, in a press release. “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 cluster will meet three to four times a year and be chaired jointly by EMA and FDA. The first meeting took place June 22, 2016.