United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
60 days
official guidance
Legal time limit
-
Not published
Steps
5
10 requirements
Application fee
£24,688
2025 to 2027 fee schedule
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. The same product was approved by a reference regulator within the previous 2 years, with the same manufacturing process, and none of the Recognition B triggers apply.
The official review target is 60 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The recognition a, major application (new active substance) is £24,688 for 2025 to 2027 fee schedule.
1. Eligibility form; 2. Submission; 3. Validation (14 days); 4. Targeted assessment (60 days); 5. Decision.
Yes. It relies on approvals from Australia, Canada, Switzerland, European Union, Japan, Singapore, United States (recognition, recognition, recognition, recognition, recognition, recognition, recognition).
Outcome: A UK-wide marketing authorisation.
Legal basis: Human Medicines Regulations 2012 (regulations 50, 51B, 52B, 53B and 55 applications), International Recognition Procedure
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 74 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Validationofficial guidance. Validation period. | 14 days |
| Review targetofficial guidance. No clock stop. Official target, not an actual time. | 60 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Recognition A, major application (new active substance)Application · 2025 to 2027 fee schedule | £24,688 |
| Recognition A, complex applicationApplication · 2025 to 2027 fee schedule | £13,983 |
| Recognition A, standard applicationApplication · 2025 to 2027 fee schedule | £7,743 |
Other routes in United Kingdom: National assessment for innovative medicines, National assessment for established medicines, Generic medicine application, Biosimilar application, Well-established use application, Reclassification to pharmacy or general sale, International Recognition Procedure, Recognition B, Project Orbis (cancer medicines), Conditional marketing authorisation, Authorisation under exceptional circumstances, Orphan designation, Early Access to Medicines Scheme (EAMS), Innovative Licensing and Access Pathway (ILAP), Rolling review, MHRA-NICE aligned pathway. See all routes on the United Kingdom page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (33 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.