United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
150 days
official guidance
Legal time limit
210 days
regulation
Steps
10
9 requirements
Application fee
£124,194
2025 to 2027 fee schedule
The MHRA route for new active substances and all biological medicines, including vaccines and cell and gene therapies. A positive decision is possible within 150 clock-on days when one round of questions resolves all issues. The final decision comes within 210 clock-on days. New active substances, all biological products (including vaccines, biosimilars and advanced therapies), new combinations, orphan medicines, and conditional or exceptional circumstances applications.
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.
The national application fee, new active substance (major application) is £124,194 for 2025 to 2027 fee schedule.
1. Advance notice of submission; 2. Submission on a monthly deadline; 3. Validation (21 days); 4. Initial assessment to Day 90 (90 days); 5. Applicant answers first questions; 6. Assessment of answers to Day 150 (60 days); 7. Second round for minor issues; 8. Commission on Human Medicines letter; 9. Final checks and decision by Day 210; 10. Decision and public report.
Outcome: A UK-wide marketing authorisation, valid for five years at first. Valid for 5 years.
Legal basis: Human Medicines Regulations 2012, regulations 49, 50 and 58 and Schedule 8
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 537 days end to end with the official step targets, of which up to 457 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
| Review targetofficial guidance. Possible positive decision by Day 150 when one round of questions resolves all issues. Official target in calendar days, not an actual review time. Time the applicant takes to answer questions does not count. | 150 days |
| Longest clock stopofficial guidance. Up to 6 months for answers to the first request for information. | 183 days |
| Legal time limitregulation. The law asks the agency to take all reasonable steps to decide within 210 days. The period is suspended while requested information is awaited. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| National application fee, new active substance (major application)Application · 2025 to 2027 fee schedule · Small companies can pay 25% of the fee at submission and the rest within 30 days of the decision. | £124,194 |
| Annual periodic fee for holding an authorisation for a new active substance (first five complete fee periods)Yearly · 2025 to 2027 fee schedule | £11,627 |
Other routes in United Kingdom: 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), 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 (40 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.