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BMA briefing: medicine and medical device regulation

Collaboration across borders on the way medicines and medical devices are regulated has been a key advantage of the UK’s membership of the EU. Establishing a robust common framework for assessing and monitoring drug safety and efficacy has meant patients across Europe have timely access to new therapies and technologies.

The CE marking system for medical devices has facilitated access to innovative medical devices from across Europe. The UK’s decision to leave the EU has the significant risk of limiting the benefits of this harmonised approach. It is vital that the UK Government’s negotiations with the EU prioritise the ability for the UK and EU to work closely across these areas.

 

Key points

The UK has developed a well-functioning medicines and medical devices regulatory system, working with the EMA (European Medicines Agency) and built on EU (European Union) regulations and directives.
  

Adopting a divergent approach to licensing would lead to:

  • delayed access to new medicines and medical devices – it has been suggested a separate regulatory system for medicines could lead to delays of 12 to 24 months in accessing life-saving drugs;
  • weaker post-approval regulation and pharmacovigilance, by lessening capacity to manage and detect issues such as adverse drug reactions; and
  • loss of expertise in regulatory processes and pharmacovigilance.

To minimise these potential impacts, the UK Government should:

  • work closely with the EMA through a formal agreement to continue to support and participate in their assessments for medicines approvals;
  • agree mutual recognition of and ongoing participation in the CE-mark scheme.

 

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Brexit briefing: Medicines and medical devices regulation

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Find out more

For further information on this briefing, please contact Susan Bahl, Brexit lead:

 

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