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.
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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.
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New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.