United Kingdom · Medicines and Healthcare products Regulatory Agency · Cell and gene therapy
Review target
150 days
official guidance
Legal time limit
210 days
regulation
Steps
4
6 requirements
Application fee
-
Gene therapies, somatic cell therapies and tissue engineered products need a UK-wide marketing authorisation. They follow the innovative medicines route, with extra rules on follow-up and, for point of care products, on manufacturing. Any gene therapy, somatic cell therapy or tissue engineered product, including combined products with a device.
The official review target is 150 days (official guidance). The legal time limit is 210 days. Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Classification advice; 2. UK-wide application; 3. Assessment; 4. Decision.
Outcome: A UK-wide marketing authorisation.
Legal basis: Human Medicines Regulations 2012, regulations 50, 50H, 50K and 58
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. Official target in calendar days, not an actual review time. Time the applicant takes to answer questions does not count. | 150 days |
| Legal time limitregulation. Period suspended while requested information is awaited. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in United Kingdom: National assessment for innovative medicines, 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), 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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.