United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
£4,845
2025 to 2027 fee schedule
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. Potentially transformative medicines or drug-device combinations with early human safety data, before confirmatory trials start.
The target development profile is £4,845 for 2025 to 2027 fee schedule.
1. Innovation Passport application; 2. Target Development Profile; 3. Ongoing coordinated support.
Outcome: Coordinated development support; the medicine still needs a marketing authorisation.
Legal basis: MHRA program delivered with UK health technology assessment bodies and the NHS
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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Target Development ProfileOther · 2025 to 2027 fee schedule | £4,845 |
| Innovation PassportDesignation · 2025 to 2027 fee schedule | £3,945 |
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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.