Massive Reallocation of UK Rapporteurships Likely As EMA Plans For Future; UK’s Interim Role Uncertain
If Brexit means the UK no longer plays a part in the EU drug regulatory system, responsibility for the ongoing oversight of almost one in four of all the human medicines that have ever been approved under the centralized procedure will have to be reassigned from the UK to other member states. What Brexit means for the UK’s role as a key player in the regulatory system in the meantime is the subject of speculation.
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The EMA says the UK is continuing to bid for EU regulatory work as the Brexit date of March 29, 2019 draws nearer. The head of the BioIndustry Association says this is something of a “pushback” against efforts to squeeze the UK out of its EU regulatory role in preparation for Brexit.
The UK MHRA says it plans to continue playing a full part in the EU regulatory network as Brexit negotiations continue, while a task force at the EU industry body EFPIA has discussed contingency planning and other issues.
A survey of EFPIA member companies has revealed some alarming statistics on the effects that a “no-deal” Brexit would have on trade, marketing authorizations, batch release and clinical trials.