Pink Sheet

UK Explains New Reliance Routes To Approval Based On EU Dossiers

By Ian Schofield 27 Jan 2021

Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.

Topic Brexit Pharma-Brexit

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UK BIA To Push For Post-Brexit Regulatory Agreement With EU

By Ian Schofield 27 Jan 2021

There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.

Topic Regulation Brexit Pharma-Brexit

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How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1

By Ian Schofield 27 Nov 2020

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.

Topic Pharma-Brexit Brexit Regulation

Pink Sheet

Desperate Measures: How To Soften The Impact Of No-Deal Brexit

By Ian Schofield 27 Nov 2020

Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.

Topic Pharma-Brexit Brexit EU

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Brexit: New Rules Will Hit Parallel Trade From UK to EU

By Ian Schofield 23 Nov 2020

From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries. 

Topic EU Pharma-Brexit Brexit

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Brexit Issues Lead NICE To Delay Methods Review

By Francesca Bruce 23 Nov 2020

England’s health technology appraisal body, NICE, and the UK medicines regulator, the MHRA, are working together to align their process timelines so that access to medicines is “maintained and enhanced.”

Topic Brexit Pharma-Brexit EU

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Brexit: UK Joining US-Led Project Orbis To Speed Cancer Drug Approvals

By Neena ​ Brizmohun 23 Nov 2020

Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.

Topic Pharma-Brexit Brexit

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UK Firms Face Thousands Of Variations To Update Safety Information

By Vibha Sharma 23 Nov 2020

With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.

Topic Pharma-Brexit Safety Brexit

Pink Sheet

Act Quickly On Converted EU Product Approvals GB Firms Urged

By Ian Schofield 23 Nov 2020

The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year. 

Topic Pharma-Brexit Brexit Approvals