MHRA announces international partnerships to accelerate medicines approvals 8 Jun 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new international framework that will help bring new medicines to patients faster.

These new regulatory recognition routes rely on the expert decisions of seven trusted regulatory agencies around the world, namely those from Australia, Canada, the EU, Japan, Switzerland, Singapore and the US.

The routes will sit alongside the MHRA’s innovation pathway for medicines, which integrates early regulatory advice with health technology assessment advice. The MHRA will still be responsible for approving all ‘recognition route’ applications and retains the authority to reject applications that do not reach the correct standard.

The new system will be in place by the first quarter of 2024 and will replace the temporary EU ‘reliance’ routes that expire at the end of 2023.

This important legislation sits alongside a package of other measures designed to accelerate medicines approvals in the UK, including recommendations outlined in the ‘Pro-innovation Regulation of Technologies Review – Life Sciences’ that was published on 25 May 2023.