Historically, centralized European Commission approvals have applied to the UK.

Since January 2021, however, as a result of the UK leaving the EU, the MHRA has been the sovereign regulator for Great Britain (England, Scotland and Wales), although a reliance arrangement was put in place that enabled the MHRA to use EU decisions beyond this date.(Also see "UK Avoids 'Cliff Edge' By Extending EU Drug Approval Reliance Procedure" - Pink Sheet, 3 October, 2022.).

Due to the Northern Ireland protocol, EU authorizations still apply in the nation, although from January 2025 the MHRA will be able to approve innovative new medicines UK-wide under the Windsor Framework.(Also see "EU Adopts New Rules On UK-Wide Approvals For Novel Drugs" - Pink Sheet, 30 May, 2023.).

There are also several regulatory pathways available to companies looking to secure an MHRA authorization for a medicine, including the new International Recognition Procedure.(Also see "UK’s New International Recognition Procedure A ‘Win-Win’ For Stakeholders" - Pink Sheet, 2 January, 2024.).

However, filing a new medicine or applying for an indication extension to an approved drug through any pathway still requires substantial financial and logistical resources that might not be recovered unless a company secures NHS reimbursement for a drug.

One In Five English HTAs Terminated Due To Company Non-Submissions And Withdrawals

More from Europe

More from Geography