EMA FDA holding hands
June 27, 2016
The European Medicines Agency
(EMA) and the United States Food
and Drug Administration (FDA)
have announced the establishment
of 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, according to an
announcement about the new
collaboration.
“Our aim as regulators is to make
sure that patients have access to
safe and effective medicines that
improve their lives,” explains Guido
Rasi, EMA executive director.
Many of the challenges and
benefits of working with patients
are similar for both regulators, he
said, so it makes sense “to benefit
from each other’s experience”.
The FDA and EMA also conduct
‘cluster’ discussions relating to
biosimilars, cancer medicines,
orphan drugs, medicines for
children and pharmacovigilance.
Other global ‘harmonisation’
relates to nomenclature for
medicines which has also reached
our own shores (PD 09 Feb 16).
The new jointly chaired cluster
will meet up to four times per year
by teleconference, the release said.
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