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Regulatory News | 22 June 2016 | By Zachary Brennan
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Wednesday began exchanging more information on the best practices of involving patients in the development, evaluation and post-authorization tracking of medicines.
The EMA/FDA teleconference, also known by EMA as a "cluster," on patient engagement seeks to increase the exchange of information on engaging with and involving patients and their organizations within the regulators’ work, as well as exchanging more information on internal policies, guidance documents and regulations, particularly for high-profile products/topics of mutual interest.
The two drug regulators also hold regular teleconferences on:
Areas of future discussion on patient engagement will also include the processes for selecting and preparing patients to take part in the agencies’ activities, how to ensure that patients are independent and representative, and how to report on the impact of patient involvement, EMA said.
“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,” Guido Rasi, EMA executive director, added. “Many of the challenges and benefits of working with patients are similar for both regulators.”
The new cluster is expected to meet three to four times per year via hour-and-a-half long teleconferences, and will involve officials from FDA’s Office of International Programs, Office of Health and Constituent Affairs, as well as from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. The clusters will be chaired jointly by FDA and EMA.
Terms of reference for the EMA/ FDA cluster on patient engagement
EMA and FDA reinforce collaboration on patient engagement
Tags: EMA cluster, patient engagement, drug regulators working with patients