The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the International Recognition procedure (IRP), a new pathway for medicine approvals.
Effective from 1 January 2024, the IRP will streamline the process by incorporating assessments from trusted regulatory partners worldwide.
The IRP is a post-Brexit initiative aimed at ensuring UK patients have timely access to life-saving medicines.
Developers of new medicines targeting the UK market can now utilise the IRP, which allows the MHRA to leverage the expertise of international regulatory bodies.
This collaborative approach is expected to make the authorisation process more efficient and cost-effective.
While the MHRA maintains the final decision-making authority, the shared knowledge from global partners is anticipated to accelerate the approval timelines.
The UK regulator will establish partnerships with regulatory agencies in Australia, Canada, Japan, Singapore, Switzerland and the US. It will also collaborate with the European Medicines Agency.
The IRP offers two distinct routes for submission, with the MHRA setting authorisation timeframes between 60 to 110 days, a significant reduction from the current 150-day standard.
MHRA healthcare quality and access interim executive director Julian Beach stated: “With this new application procedure fully live, we are delighted to have created a further, innovative route for bringing new medicines to UK patients.
“IRP allows us to access the expertise of trusted regulatory partners, who have already authorised products.
“In return, our partners can consider applications based on MHRA authorisations, creating a 'win-win' for regulators, developers of innovative treatments and patients.”
To assist applicants with the IRP, the MHRA introduced an eligibility checker tool on 20 November 2023.
The tool guides applicants in determining the suitability of their marketing authorisation application and advises on the appropriate submission route.
Applicants are encouraged to use the eligibility checker six weeks before their full IRP submission.
