How the UK borrows other countries' homework to approve medicines faster

What happened

On 3 September 2026, the UK's medicines regulator updated part of the paperwork behind one of its faster approval routes. The regulator is the Medicines and Healthcare products Regulatory Agency, usually called the MHRA. It is the body that decides whether a medicine can legally be sold and used in the UK. The route in question is called the International Recognition Procedure, or IRP. The update was to the eligibility checker, which is the form a company fills in to find out whether its application qualifies for this route and, if so, which version of it. On its own, an updated form is a small administrative change. It is not a new medicine or a new treatment. But it is a useful moment to explain something that affects almost everyone who takes a prescription, and that very few people have ever had explained to them: how a medicine actually gets approved in the UK, and why some arrive faster than others. The International Recognition Procedure has been running since 1 January 2024. It lets the MHRA take account of a decision already made by a trusted regulator in another country, rather than starting the assessment from scratch. There are seven regulators whose approvals can be used this way. They are the Therapeutic Goods Administration in Australia, Health Canada, the European Medicines Agency and EU member state authorities, the PMDA in Japan, the Health Sciences Authority in Singapore, Swissmedic in Switzerland, and the Food and Drug Administration in the United States.

Why this matters

Before Brexit, the UK took part in the European system for approving medicines. After leaving, it needed its own way of doing things. One option would have been to assess every single medicine from the beginning, no matter how thoroughly it had already been examined elsewhere. That would be slow and would duplicate an enormous amount of work. It would also risk the UK becoming a less attractive place to launch a medicine, which can mean patients here waiting longer than patients elsewhere. The International Recognition Procedure is the answer to that problem. It is a way of saying: another serious regulator has already examined this in detail, so we will take that into account rather than repeating everything. For patients, the practical effect is about time. Waiting for a treatment is not an abstract inconvenience when you have a condition that is getting worse. It matters for the NHS too. Getting a medicine licensed is only the first step. It then has to be assessed for value and made available. A delay at the start pushes everything else back. There is a second reason this is worth understanding. When people hear that an approval was 'fast-tracked', it can sound alarming, as though corners were cut. Knowing how these routes actually work makes it easier to judge that fairly.

What the evidence actually says

The most common misunderstanding about this route is worth addressing directly. Recognition is not the same as rubber-stamping. The MHRA's own guidance is explicit on this. It states that the agency 'will conduct a targeted assessment of IRP applications but retain the authority to reject applications if the evidence provided is considered insufficiently robust'. In plain terms: the MHRA still looks at the application, and it can still say no. There are also strict conditions on what can be submitted. The product must be the same product that the other regulator approved. That means the same composition, the same form, and the same pharmaceutical characteristics. A company cannot get approval abroad for one version of a medicine and then use that to wave through a different one here. The procedure has two versions. Recognition Route A has a 60-day timetable. Recognition Route B is more thorough and takes 110 days. The eligibility checker, which is what was updated on 3 September, is the tool that helps applicants work out which of these two routes their application belongs in. It is worth keeping the size of this news in proportion. This was an update to a form, not a change to the standard of evidence required. Anyone suggesting that safety rules have been loosened would be reading far more into it than is there. Equally, it would be wrong to dismiss the wider system as unimportant. Which route a medicine takes can affect whether it reaches UK patients months earlier or later.

Qurexa perspective

We deliver prescriptions, so the end of this process is our daily business. By the time a medicine reaches someone's front door, it has passed through years of research, a regulator's assessment, decisions about NHS funding, and a supply chain. Most people never see any of that, and there is no reason they should have to. But we think it is worth knowing that a licensed medicine in the UK has been through a genuine assessment, whichever route it took. If you are ever unsure whether something you have been offered is a licensed medicine, particularly if you have found it online, your pharmacist can tell you. It is a question worth asking before you spend money or take anything.

Practical advice

This is mostly a story about how the system works behind the scenes, but there are some genuinely useful things to take from it. Be careful buying medicines online. A licensed UK medicine has been assessed by the MHRA. Something bought from an unregulated website may not have been assessed by anyone. In the UK, registered online pharmacies can be checked through the General Pharmaceutical Council register. If a medicine is not available on the NHS, ask why. There is a difference between a medicine that is not licensed at all and one that is licensed but not funded for your particular situation. Those are two separate questions with different answers. Report side effects. The MHRA runs the Yellow Card scheme, and anyone can use it, including patients and carers. Approval is not the end of monitoring. Real-world reports are how rare problems get spotted. Do not stop a prescribed medicine because of something you have read. Speak to your prescriber or pharmacist first. If you struggle to keep track of several medicines, ask your pharmacy about a medicines review. Many pharmacies can go through everything with you and check that it all still makes sense together.

What to know

On 3 September 2026, the MHRA updated the eligibility checker form for its International Recognition Procedure. This is an administrative update rather than a change to safety standards. The International Recognition Procedure has operated since 1 January 2024. It allows the MHRA to take account of approvals already granted by regulators in Australia, Canada, the EU, Japan, Singapore, Switzerland and the United States. The medicine must be the same product that the other regulator approved, with the same composition and form. The MHRA still carries out its own targeted assessment and can reject an application if the evidence is not robust enough. Route A takes 60 days and the more detailed Route B takes 110 days. If you have questions about a medicine you take, your pharmacist is a good first port of call. Side effects can be reported through the MHRA's Yellow Card scheme. Sources: MHRA guidance on the International Recognition Procedure, updated 3 September 2026, https://www.pharmavibes.co.uk/2026/09/03/mhra-guidance-on-the-international-recognition-procedure-irp-commencing-in-2024/ | Medicines and Healthcare products Regulatory Agency, GOV.UK, https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency | Regulatory Affairs Professionals Society, 'MHRA touts uptick in approvals in 2025-2026 annual report', https://www.raps.org/resource/mhra-touts-uptick-in-approvals-in-2025-2026-annual-report.html This article is for general information and does not replace advice from a doctor, pharmacist or other qualified healthcare professional. Never start, stop or change a prescribed medicine without speaking to your prescriber or pharmacist first.