EMA and FDA Begin Collaborations on Patient Engagement

Regulatory NewsRegulatory News | 22 June 2016 |  By 

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:

  • Advanced-therapy medicinal products (five or six teleconferences per year alongside Health Canada)
  • Biosimilars (three times per year with Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA))
  • Blood products (quarterly teleconferences with Health Canada)
  • Oncology-hematology products (monthly teleconferences with Health Canada, PMDA and Australia’s Therapeutic Goods Administration (TGA))
  • Non-clinical oncology (quarterly teleconferences)
  • Orphan drugs (monthly teleconferences)
  • Pediatric drugs (10-12 teleconferences annually with Health Canada, PMDA and TGA)
  • Pharmacogenomics (twice annually)
  • Pharmacometrics (quarterly alongside Health Canada and TGA)
  • Pharmacovigilance (monthly teleconferences)
  • Vaccines (quarterly teleconferences with Health Canada)

Patient Engagement

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


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