UK Seeks Smooth 'Grandfathering' Of EU Centrally Approved Drugs In Event Of No-Deal Brexit
Executive SummaryIn 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...
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.
India has proposed three categories for grouping genetically edited organisms based on the complexity of modifications.
Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.