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.
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The UK government has published its response to the concerns raised by a parliamentary health committee about the impact of Brexit on medicines and medical devices. However, the response is lacking in detail, and the biotech industry says it does not provide the information companies need to be able to plan for the future.
The UK will be able to play a full part in the EU’s new clinical trial system if the legislation takes effect during a Brexit transition period. However, if there is no transition period, the extent of its future participation in the new trials portal is far from certain.
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.