UK Health Committee Wants Clear Answers On Future Links Between MHRA And EMA
Sarah Wollaston, chair of the Commons health committee, has asked the government to clarify its intentions for the relationship between the UK MHRA and the EMA during and after any Brexit transition period.
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EU leaders have endorsed the “political declaration” outlining the aspirations for the future relationship between the UK and the EU after Brexit, together with the much larger withdrawal deal. The life sciences industry will be disappointed that in the drug regulatory area the political declaration contains little beyond an aspiration for “possible” cooperation between the UK drug regulator and the European Medicines Agency.
The EU has agreed to a Brexit transition period and adopted guidelines on its talks with the UK on their future relationship. But while the political agreement on the transition will give the life sciences industry some certainty, it is not yet a done deal and the regulatory implications are still unclear.
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.