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EMA defends its own transparency

THE European Medicines
Agency has issued a formal
response to an article in the
British Medical Journal which
called for more transparency
from medicines regulatory
agencies.
In a letter to the BMJ the
Agency has outlined a number
of steps taken to increase its
transparency, including a new
‘access to documents’ policy
which came into effect last
November, as well as the
launch of the European Union
Clinical trials Register.
The EMA has also launched
public consultations on a draft
transparency policy, as well as
on the release of safety data
held in the so-called
EudraVigilance database.
Agency acting executive
director Andreas Pott said
recent moves would strengthen
the EMA’s approach to
“proactive and reactive
dissemination of information
on the quality, safety and
efficacy of medicines”.