UK MHRA Looks Beyond Brexit Transition
Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.
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Could the UK carry on playing a part in the European Medicines Agency from 2021? Much will depend on the complex negotiations on the future relationship that are expected to kick off in March.
Some changes have been made to UK legislation that will aim to ensure the effective operation of the regulatory system once the country leaves the EU. Areas affected include the QPPV, pediatric and orphan medicines, and the reference product for generic approvals.
The UK medicines regulator is exploring how it can focus its pharmacovigilance inspections on areas of high-risk and reduce the number of days it spends on inspections. To this end, office-based inspections have emerged as a useful concept, and there are plans to use this approach more vigorously.