UK Seeks Smooth 'Grandfathering' Of EU Centrally Approved Drugs In Event Of No-Deal Brexit
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...
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.
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.