The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have created a new collaboration on patient engagement. It will give an opportunity to share experiences and best practices on the way the two agencies involve patients in progress, assessment and post-authorization actions related to medicines. The first meeting took place by teleconference on 22 June 2016.
According to Guido Rasi, EMA Executive Director, “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,”
The collaboration established by EMA and regulators outside the European Union focus on definite topic areas where the parties involved could gain an immense exchange of information. The presently offered EMA/FDA collaboration discusses problems correlated to:
- Biosimilars
- Medicines to treat Cancer
- Orphan medicines
- Medicines for children
- Pharmacovigilance
The increased interaction will allocate EMA and FDA to exchange information to extent the future rendezvous with patients. The information exchange is covered by the confidentiality arrangements between the two regulators.
The main discussion topics will comprise:
- The processes for selecting and preparing patients to take part in the agencies’ activities
- How to ensure that patients are independent and representative
- How to report on the impact of patient involvement
It is expected that three to four meetings will be arranged per year via teleconference and will be chaired in cooperation by FDA and EMA.
Dated: 22/06/2016