Tuesday, 6 June 2017

Drug Safety and Brexit

There have been talks about what would happen once UK leaves EU which has put lot of QPPV (Qualified Persons Responsible for Pharmacovigilance) in UK in dilemma as the regulations say that the QPPV should be a part of the EU, with the impact Brexit it will hit the pharmacovigilance system in UK as EU would not be obliged to carry out Post marketing surveillance in UK.

Currently June Raine who is chairing the Pharmacovigilance Risk Assessment Committee ( part of the European Medical Agency, in which there are two members from each member state) is from the Medicines and healthcare products regulatory agency (MHRA) of the UK.

There have been discussions about QPPV who still want to be a part of EU which might eventually lead to a negotiation between EMA and UK to collaborate pharmacovigilance activities together, as pharmacovigilance is above politics.

By Joseph Mathew
Sr. Manager- Think i

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