1. Pink Sheet
  2. >>Geography
  3. >>Europe

Getting Ready For The Windsor Framework: Ensuring Continuity Of UK Medicines Supply Beyond 1 January 2025

There are increased complexities associated with potential regulatory divergence between the UK and the EU when the Medicines and Healthcare products Regulatory Agency takes over responsibility for UK-wide new drug approvals from January 2025, writes the ABPI's Rick Greville.

Windsor framework agreement concept
The Windsor Framework takes full effect next year • Source: Shutterstock

The Windsor Framework, agreed between the UK and the EU in February 2023, is expected to be fully implemented on 1 January 2025. The agreement seeks to resolve some of the issues with the Northern Ireland Protocol identified by businesses and communities, but the new framework does not entirely replace all the protocol’s provisions.

The new Labour government has continued progress towards implementation of the Windsor Framework. Just before the summer parliamentary recess, updates...

Welcome to Pink Sheet

Create an account to read this article

Already a subscriber?

More from Europe

New EU Filings

 
• By Neena Brizmohun

Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
• By Neena Brizmohun

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 
• By Eliza Slawther

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.

More from Geography

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
• By Neena Brizmohun

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

 
• By Francesca Bruce

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 
• By Eliza Slawther

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.