Transparency is the driver
behind the European Medicines
Agency (EMA) adoption of what
it calls a landmark policy of
publication of clinical reports.
Based on extensive stakeholder
consultation, the unanimously
voted policy forced publication
of the clinical reports that
underpinned the decision-making
on medicines approved by the
EMA, the organisation said.
The policy comes into force 01
Jan 2015 and will apply to clinical
reports contained in all applications
for marketing authorisations
submitted after that date.
EMA executive director Guido Rasi
said the policy set a new standard
for transparency in public health
and pharmaceutical research and
development.
“This unprecedented level of
access to clinical reports will benefit
patients, healthcare professionals,
academia and industry.”
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