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23rd Jul 2012, 12:47 PM
#4
FYI - the new (17 Jul 2012) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC states that the annual safety report is not submitted for authorised investigational medicinal products that are used within their authorised indication.
This should reduce the number of DSURs a non-commercial sponsor would have to prepare. Expected to come into effect in 2016.
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