The European CRO Federation is calling to widen the scope of a proposed delegated act related to pharmacovigilance legislation to include scenarios when observational PAES (post-authorisation efficacy studies) will be required.
The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.
The EC says proposals to replace the Clinical Trials Directive with simplified rules will make Europe more attractive for trials, but what do CROs think? Share your opinions in this exclusive Outsourcing-pharma.com poll.
European pharmaceutical manufacturers stepped up calls for a
blanket ban on repackaging of pharmaceuticals last week, suggesting
that this would be the single most effective way to seal the supply
chain for counterfeiting drugs.
European and US regulatory bodies have revamped their relationship
to ease administrative burdens and improve communication, as well
as implementing new measures directed specifically at paediatric