UK Seeks Smooth 'Grandfathering' Of EU Centrally Approved Drugs In Event Of No-Deal Brexit
Executive Summary
In preparation for a possible no-deal Brexit, the UK medicines regulator is pressing on with its plans to facilitate the automatic conversion of EU centrally authorized products to UK marketing authorizations. Affected sponsors are being asked to undertake certain actions to ensure the process runs smoothly.
You may also be interested in...
How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1
Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.