How medicines and medical devices get approved in United Kingdom

The MHRA route for new active substances and all biological medicines, including vaccines and cell and gene therapies. A positive decision is possible within 150 clock-on days when one round of questions resolves all issues. The final decision comes within 210 clock-on days.

Full application, new active substance · target 150 days · verified October 3, 2026

The MHRA route for medicines that do not meet the innovative criteria, such as known active substances, new forms of established products and hybrid applications. The agency aims for a final decision within 210 days, not counting clock stops.

Full or mixed application, known active substance · target 210 days · verified October 3, 2026

An application that relies on published scientific literature instead of the applicant's own trials. The active substances must have been in well-established medicinal use for at least 10 years, with recognised efficacy and acceptable safety.

Well-established use · target 210 days · verified October 3, 2026

A fast route for a medicine already approved by a trusted reference regulator within the last 2 years. The MHRA runs a targeted assessment on a 60-day timetable with no clock stop.

Reliance route, recognition or verification · target 60 days · relies on AU, CA, CH, EU, JP, SG, US · verified October 3, 2026

A recognition route for medicines approved by a reference regulator within the last 5 years, or that need more assessment than Recognition A allows. It runs on a 110-day timetable with one clock stop at Day 70.

Reliance route, recognition or verification · target 110 days · relies on AU, CA, CH, EU, JP, SG, US · verified October 3, 2026

A program led by the US FDA for concurrent review of promising cancer medicines with partner regulators. The MHRA reviews on its innovative medicines timetable and makes its own decision.

Work-sharing or joint review · target 150 days · relies on US · verified October 3, 2026

An authorisation granted before full clinical data are available, for medicines that meet an unmet need in serious or life-threatening diseases or public health emergencies. It lasts one year and is renewed each year until the obligations are met.

Conditional or accelerated approval · verified October 3, 2026

An authorisation for medicines where full data on efficacy and safety cannot be provided, because the condition is rare or collecting the data is not possible or unethical. It carries specific obligations and is reviewed every year.

Approval under exceptional circumstances · verified October 3, 2026

Orphan status for medicines for rare, life-threatening or chronically debilitating conditions. The MHRA decides it when it grants the marketing authorisation. It brings ten years of market exclusivity, which can be twelve years with paediatric rewards.

Orphan or rare disease designation · verified October 3, 2026

Lets patients with life-threatening or seriously debilitating conditions use a promising medicine before it is licensed. It has two steps: a Promising Innovative Medicine designation, then a scientific opinion that lasts one year.

Early or compassionate access · target 75 days · verified October 3, 2026

A joint support program run by the MHRA, health technology assessment bodies and the NHS for potentially transformative medicines. It starts with an Innovation Passport and a Target Development Profile, then gives coordinated support and priority access to services.

Intensive development support designation · verified October 3, 2026

Lets the applicant send dossier modules one at a time for pre-assessment, each in a 60-day cycle. The final application then has a 100-day final phase, split 60 plus 40 days with a clock-off period.

Rolling or phased review · target 100 days · verified October 3, 2026

An optional way to line up the MHRA licensing decision with the NICE technology appraisal in England, so NHS access can start sooner. Each body still assesses the evidence on its own.

Other route · verified October 3, 2026

A biosimilar shows that it is highly similar to a UK reference biological medicine. The MHRA handles it on the innovative medicines timetable. In most cases a comparative efficacy trial may not be needed when the science supports this.

Biosimilar application · target 150 days · verified October 3, 2026

A generic can leave out its own preclinical and clinical trial results when it is a generic of a UK reference medicine authorised for at least eight years. It cannot be sold until ten years after the reference medicine was first authorised.

Generic application · target 210 days · verified October 3, 2026

Moves a medicine from prescription only (POM) to pharmacy (P), or from pharmacy to general sale (GSL). A major reclassification without an analogous product may need advice from the Commission on Human Medicines.

Non-prescription application · target 120 days · verified October 3, 2026

Before each batch of certain vaccines and blood products is sold, it must be independently tested and certified by the UK National Control Laboratory, which is part of the MHRA. The holder can release the batch once the certificate is issued.

Other route · verified October 3, 2026

Gene therapies, somatic cell therapies and tissue engineered products need a UK-wide marketing authorisation. They follow the innovative medicines route, with extra rules on follow-up and, for point of care products, on manufacturing.

Full application, new active substance · target 150 days · verified October 3, 2026

A device that includes a medicinal substance with a supporting (ancillary) action, such as a heparin-coated catheter, is regulated as a class III device. The approved body must consult the MHRA on the substance. Integral single-use drug-device products, such as pre-filled syringes, are licensed as medicines instead.

Device: conformity assessment by a certification body · verified October 3, 2026

Makers of low-risk Class I devices that are not sterile and have no measuring function declare conformity themselves, affix the UKCA mark and register the device with the MHRA. No approved body is involved.

Device: registration or licence with the regulator · verified October 3, 2026

Medium and high-risk devices, and Class I devices that are sterile or measure, need a conformity assessment by a UK approved body. The body reviews clinical data, manufacturing and the quality system, then issues a UKCA certificate. The device is then registered with the MHRA.

Device: conformity assessment by a certification body · verified October 3, 2026

Great Britain accepts CE marked devices for a set time. Devices under the EU MDR or IVDR can be placed on the market until 30 June 2030. Older EU directive devices have earlier end dates. Registration with the MHRA is still required.

Reliance route, recognition or verification · relies on EU · verified October 3, 2026

Most lower-risk in vitro diagnostics are general IVDs. The maker declares conformity, affixes the UKCA mark and registers the IVD with the MHRA. No approved body is needed.

Device: registration or licence with the regulator · verified October 3, 2026

Higher-risk IVDs need a UK approved body. Self-test IVDs need a design examination. List A and List B IVDs need quality system audits or type examination, and List A batches are verified before release.

Device: conformity assessment by a certification body · verified October 3, 2026