United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
75 days
official guidance
Legal time limit
-
Not published
Steps
7
4 requirements
Application fee
£31,214
2025 to 2027 fee schedule
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. Unlicensed medicines or new indications for serious conditions with high unmet need, usually at least 6 months before the expected authorisation.
The official review target is 75 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The eams scientific opinion, new medicinal product is £31,214 for 2025 to 2027 fee schedule.
1. Apply for PIM designation; 2. Designation meeting (42 days); 3. PIM decision (28 days); 4. Pre-submission meeting; 5. Scientific opinion assessment (45 days); 6. Applicant answers; 7. Final scientific opinion.
Outcome: A published scientific opinion that supports early use, valid for one year. Valid for 1 years.
Legal basis: MHRA scientific opinion under the Early Access to Medicines Scheme
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 145 days end to end with the official step targets, of which up to 30 days are clock stops (time the applicant uses to answer). 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
| Longest clock stopofficial guidance. 30-day clock stop on the Day 90 timetable (60 days in exceptional cases). | 30 days |
| First review cycleofficial guidance. Initial scientific opinion by Day 45. Official target. | 45 days |
| Review targetofficial guidance. Day 75 timetable after a positive initial opinion; Day 90 after a negative one. | 75 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| EAMS scientific opinion, new medicinal productApplication · 2025 to 2027 fee schedule | £31,214 |
| EAMS renewal, new medicinal productRenewal · 2025 to 2027 fee schedule | £15,607 |
| EAMS scientific opinion, new indicationApplication · 2025 to 2027 fee schedule | £10,115 |
| EAMS renewal, new indicationRenewal · 2025 to 2027 fee schedule | £5,057 |
| Promising Innovative Medicine designationDesignation · 2025 to 2027 fee schedule | £4,852 |
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, 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 (27 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.