United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
100 days
official guidance
Legal time limit
-
Not published
Steps
6
3 requirements
Application fee
£31,049
2025 to 2027 fee schedule
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. Full-dossier new active substances and biosimilars where data become available in stages.
The official review target is 100 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The rolling review pre-assessment, new active substance, per module (modules 3, 4 or 5) is £31,049 for 2025 to 2027 fee schedule.
1. Pre-submission meeting; 2. Module pre-assessment (60 days); 3. Final application; 4. Final phase, first stage (60 days); 5. Clock off for questions; 6. Final phase, second stage and decision (40 days).
Outcome: A UK-wide marketing authorisation if approved.
Legal basis: Human Medicines Regulations 2012, regulation 50 or 53B; MHRA rolling review 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 160 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
| First review cycleofficial guidance. Each module assessment cycle. Official target. | 60 days |
| Review targetofficial guidance. Final phase of 60 plus 40 days, with a clock-off period between them. | 100 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Rolling review pre-assessment, new active substance, per module (modules 3, 4 or 5)Other · 2025 to 2027 fee schedule | £31,049 |
| Rolling review pre-assessment, biosimilar, per module (modules 3, 4 or 5)Other · 2025 to 2027 fee schedule | £5,802 |
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 A, International Recognition Procedure, Recognition B, Project Orbis (cancer medicines), Conditional marketing authorisation, Authorisation under exceptional circumstances, Orphan designation, Early Access to Medicines Scheme (EAMS). See all routes on the or explore them in the .
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 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.