Post-Brexit UK Could Lose Access To EU’s Drug Safety Database
One of the many ramifications of the UK’s decision to leave the EU is that it could lose access to the revamped EudraVigilance adverse drug reaction database.
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Losing access to the EudraVigilance drug safety database after Brexit could lead to delays of up to two months in safety signal detection, and up to five months’ delay in managing new signals, says an alliance of industry, UK National Health Service bodies and medical charities. The alliance also warns that efforts to tackle infectious diseases could be impaired if the UK's role in EU health risk reporting systems is diminished.
Get Full Regulatory Alignment Or See Post-Brexit Declines In Trials, Manufacturing, Product Launches, Says UK Committee
Stakeholders that gave evidence to a UK parliamentary inquiry into the impact of Brexit on medicines and medical devices said full regulatory alignment was vital if the UK was to avoid declines in clinical trial and manufacturing activity and delays in the launch of new drugs.
The UK may not be able to participate in the European Medicines Agency after Brexit, but there are plenty of precedents for informal collaboration among regulatory agencies worldwide. A former European Medicines Agency executive director and legal experts talk to the Pink Sheet about what might be possible.