EMEA worries about medicines expertise
Concern has been expressed by the European Medicines Agency (EMEA) over the future availability of scientific experts to assess new and existing medicines.
The agency’s development plan for the coming five years (PDF 490K)
says that the regulatory system will be particularly challenged by new
therapies
because of the scarcity of relevant experts and their possible involvement
with the pharmaceutical industry.
“Transparent and robust conflict of interest mechanisms, to be
operated in a smooth and practical way, will need to be available to
reassure
the public,” the plan says.
There is also concern over the degree of expertise available in other
areas arising from the continuing growth of the EU.
“Adequate measures need to be taken to ensure that the existing
pool of scientific experts is maintained at the highest level of expertise,” the
plan advises.
But the area in which the agency feels most vulnerable is ongoing pharmacovigilance. “Close
collaboration with the member states is of paramount importance,” the
development plan states. It adds that regulators will have to make sure
that the overall system is equipped to deal efficiently and quickly with
crisis situations.
This, it says, will demand robust scientific assessment, sound regulatory
action, adequate transparency and appropriate communication and monitoring
of the impact of any action taken. |
The
Pharmaceutical Journal
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