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As the European Medicines Agency (EMEA) issued in a recent press release,
it held a workshop on 12 June 2007 "as part of the public consultation on
the draft guideline on requirements for first-in-man clinical trials for
potential high-risk medicinal products."
With the draft guideline the authority wants to provide
support for transitioning "from non-clinical studies, e.g. studies in
animals or in vitro studies, to first tests in humans. It describes the
principles of a science-based approach ensuring the safety of subjects and
respecting ethical principles while allowing for flexibility."
For identifying potential risks and for implementing risk
management strategies for the phase I clinical trials some criteria have to
be considered. These criteria are also covered in the draft guideline.
During the public consultation phase these were generally supported.
However, it also generated a major debate on the concept of classification
of high-risk versus non-high-risk medicinal products. As noted in the
release, the EMEA will consider the proposals "to replace it with a risk
management and risk mitigation approach based on the concept of risk as a
continuum for all medicinal products".
The Agenda of the workshop and presentations given can be
found here:
http://www.emea.europa.eu/postconference.htm
The draft guideline can be found here:
http://www.emea.europa.eu/pdfs/human/swp/2836707en.pdf
Source:
EMEA press release
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