European Union:
European Medicines Agency Issues Policy On Publication Of Clinical Data
21 January 2015
Jones Day
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On October 2, the European Medicines Agency ("EMA")
published a new policy on the proactive disclosure of
clinical data submitted by pharmaceutical companies in the context
of marketing authorization applications. The policy would allow the
EMA to publish such data after marketing authorization has been
granted, and companies would have to redact the submitted dossier
for personal data of doctors and patients.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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