United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
150 days
official guidance
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
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. New cancer medicines or new cancer indications selected by the FDA that meet its priority review criteria.
The official review target is 150 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Selection by the FDA; 2. Submission to the MHRA; 3. MHRA assessment; 4. Independent UK decision.
Yes. It relies on approvals from United States (work sharing).
Outcome: A UK marketing authorisation or new indication.
Legal basis: Human Medicines Regulations 2012 (national marketing authorisation); innovative medicines timetable
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetofficial guidance. Innovative medicines timetable applies. Official target in calendar days, not an actual review time. Time the applicant takes to answer questions does not count. | 150 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
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, Conditional marketing authorisation, Authorisation under exceptional circumstances, Orphan designation, Early Access to Medicines Scheme (EAMS), Innovative Licensing and Access Pathway (ILAP). 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.