General information for healthcare staff, not medical advice.
The MHRA decides whether a medicine can be sold in the UK. A full national assessment runs on a 210-day timetable, while the International Recognition Procedure, in place since 1 January 2024, can take 60 or 110 days when a trusted overseas regulator has already approved the product. A fast decision is a fair subject for questions, but speed alone does not show a safety standard was lowered.
Key facts
- UK regulator
- Medicines and Healthcare products Regulatory Agency (MHRA)
- National assessment
- 210-day timetable
- International Recognition Procedure
- Started 1 January 2024. Recognition A: 60 days. Recognition B: 110 days.
- Reference regulators
- Australia (TGA), Canada (Health Canada), Switzerland (Swissmedic), Singapore (HSA), Japan (PMDA), United States (FDA), and the EU and EEA (EMA and member state regulators)
- Power to refuse
- The MHRA keeps the authority to approve or refuse under every procedure
- Example of a fast US review
- FDA approved orforglipron on 1 April 2026, 50 days after filing. MHRA authorised the tablet, sold as Foundayo, on 10 August 2026.
- After approval
- Safety monitoring continues, including MHRA Yellow Card reports
How a medicine gets a UK licence
A company applies to the MHRA for a marketing authorisation. The MHRA assesses quality, safety and effectiveness, and can seek advice from the Commission on Human Medicines. The licence sets out the approved uses, the doses, and the warnings in the Summary of Product Characteristics (SmPC).
A UK licence is separate from NHS access. After authorisation, NICE decides whether the NHS in England should fund the medicine, and the devolved nations make their own decisions. The Wegovy pill, for example, was authorised in June 2026 but is not available on the NHS.
The International Recognition Procedure
The International Recognition Procedure (IRP) lets the MHRA build on a decision already taken by a reference regulator. The MHRA carries out a targeted assessment using the reference regulator's full, unredacted assessment report.
- Recognition A runs for 60 days from validation, with no clock stop. The reference approval must date from the previous two years.
- Recognition B runs for 110 days, with one clock stop at day 70. The reference approval must date from the previous five years, reduced from ten years on 13 July 2026.
If major objections remain unresolved, the timetable moves to the longer one, and for Recognition B the MHRA seeks formal advice from the Commission on Human Medicines. The MHRA can ask for more information, extend the timetable, or refuse the application. The procedure cuts repeat work, and the decision stays with the MHRA.
Fast reviews abroad: the orforglipron example
On 1 April 2026 the US Food and Drug Administration approved orforglipron, an Eli Lilly GLP-1 tablet, 50 days after filing. The approval came under the FDA's Commissioner's National Priority Voucher pilot, which aims for a decision in about two months through closer contact with the company and rolling review. The FDA said the pilot works without compromising safety standards.
The MHRA authorised orforglipron, sold as Foundayo, for weight management and type 2 diabetes on 10 August 2026, four months after the US decision. The Foundayo page sets out the UK licence, NHS status and safety points.
Conditional approvals
Some licences come with conditions. On 3 July 2026 the MHRA granted semaglutide (Wegovy) a conditional approval for a form of liver disease, pending results from an ongoing study. A conditional licence is a documented trade-off: earlier access in exchange for more evidence later. Staff should know which licences are conditional, because the SmPC and the monitoring duties differ. The Wegovy page lists the current UK uses.
Questions to ask about any fast approval
Healthy scrutiny looks at evidence, not at speed alone. Useful questions for a team meeting or clinical governance review:
- Which regulator approved the medicine, in which country, and for which exact indication?
- Which trials support the licence, how many patients took part, and for how long?
- Which groups were excluded from the trials, and what does the SmPC say about them?
- What monitoring or further studies does the licence require?
- Is the medicine authorised in the UK, or only abroad?
The MHRA products database (opens another website) holds UK product information and public assessment reports. The EMC holds current SmPCs and patient leaflets.
When speed creates pressure at work
A new licence often brings launch targets, press coverage and patients asking for a product before staff have read the SmPC. Say your service plans to start supplying a new medicine the day after authorisation, before the SmPC is published. You are entitled to ask for the product information and training first, and to record the request. The commercial pressure guide and the guide to pressure to prescribe cover this kind of conflict. If you believe patients are at risk, the guide to raising patient-safety concerns and the speaking-up guide set out the next steps.
Safety monitoring continues after launch. Report suspected side effects of new medicines to the MHRA Yellow Card scheme (opens another website), because trial data cover far fewer people than real-world use.
Common questions
How long does the MHRA take to approve a new medicine?
A full national assessment runs on a 210-day timetable. Under the International Recognition Procedure, Recognition A takes 60 days and Recognition B takes 110 days, plus any clock stops.
Does FDA approval mean a medicine is approved in the UK?
No. A medicine needs its own UK marketing authorisation from the MHRA before supply in the UK. The MHRA can use an FDA assessment through the International Recognition Procedure, but the MHRA still makes the decision.
Does a fast approval mean a medicine is less safe?
Speed alone does not show safety was compromised. Look at the trial evidence, the conditions on the licence and the monitoring in place.
Does a UK licence mean the NHS will provide the medicine?
No. NHS access depends on separate decisions, such as a NICE appraisal in England and commissioning by the NHS.