MHRA Performance Data
Updated 16 June 2025
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Overview
Our 2024/25 business plan gave a commitment to our focus being the optimisation of our service delivery for customers. It introduced key performance indicators (KPIs) and a corporate objective to enhance the transparency and accessibility of our performance data. Here we provide the MHRA performance data for May 2025 for each KPI.
Our aim is to help applicants with decision making, based on our performance data, and to ensure greater accountability for our service delivery.
How we present performance data
We publish each KPI in full, together with a percentage to indicate performance in the last month, and year to date (YTD) averages where data is available.
We provide information on the target timeline to complete a specific regulatory function and the current average timeline. Additional context is provided to signpost applicants to additional useful information.
May performance data
As the new reporting year began on 1 April 2025, our year-to-date performance data currently reflects only two month’s figures.
We continue to report consistent performance against agreed key performance indicators in MHRA’s statutory functions: licence applications for innovative and established medicines, variations to licences, and manufacturing and distribution authorisations. Average timescales for statutory functions are reducing in most areas.
Our priority is to maintain performance to predictable and statutory timeframes. We will continue to publish monthly updates providing applicants with transparent information on expected timescales.
Other key highlights for May 2025 include:
Clinical trials and investigations: Our data show that 100% of clinical trials and investigations applications continue to be handled within statutory timescales. Combined Review approval time with the Health Research Authority is now at 60 days or less for all trials, with the latest data showing an average time for Combined Review determination (including questions raised) of 40 days in April.
Medicines licensing applications: Our data show that 100% of national licence applications continue to be assessed within our statutory timescales of 210 days: with an average timescale of 176 days in May.
Scientific advice: We continue to report a positive trend in Scientific Advice, with interventions in place leading to notable improvements in performance in May.
More resources are now available to help clear scientific advice requests and we expect further signs of positive impact to be reported in our data for future months. We will sustain this effort and by Autumn 2025, we will have restored performance in scientific advice to expected timescales, and will provide more information over the coming months as part of our wider work to further develop and enhance our scientific advice services
Find out about our work to overhaul the Scientific Advice service at MHRA.
Clinical Trial Authorisation (CTA) and Clinical Investigation applications
| Key Performance Indicator (KPI) | KPI Performance May 2025 | KPI Performance 2025/26 YTD |
|---|---|---|
| 1. We will assess 95% of all initial Clinical Trial Authorisation (CTA) and Clinical Investigation applications within their category’s statutory timeline. | 100% | 100% |
Clinical Trials
| Regulatory Service | Target (days) | Last month average (days) | Notes |
|---|---|---|---|
| Initials | 30 | 28 | The MHRA contribute performance data to the UK Clinical Research Delivery Performance Indicators Report New clinical trials regulations have now been signed into law. The new regulations will take full effect from 28 April 2026, following the 12-month implementation period. |
| Amendments | 35 | 30 |
Clinical Investigations
| Regulatory Service | Target (days) | Last month average (days) |
|---|---|---|
| Initials | 60 | 53 |
| Amendments | 21 | 3 |
Vaccine batches and blood product batches
| Key Performance Indicator (KPI) | KPI Performance May 2025 | KPI Performance 2025/26 YTD |
|---|---|---|
| 2. We will certify 95% of vaccine batches within 43 days and 95% of blood product batches within 15 days of submission. | 99% | 99% |
| Regulatory Service | Target (days) | Last month average (days) | Notes |
|---|---|---|---|
| Batch Certification: | The timescale for batch certification starts once the MHRA has receipt of all components required for the testing, not receipt of the first component. | ||
| Vaccines | 43 | 5 | |
| Blood Products | 15 | 6 |
Medicines licence applications via the national route
| Key Performance Indicator (KPI) | KPI Performance May 2025 | KPI Performance 2025/26 YTD |
|---|---|---|
| 3. We will determine 95% of medicines licence applications within 210 days via the national route. | 100% | 100% |
| Regulatory Service | Target (days) | Last month average (days) | Notes |
|---|---|---|---|
| Licensing applications: National (Established) | 210 | 176 | Find out more about our work to embed improvements in processing medicines licensing applications in standard working practice. |
| Licensing applications: National (new active substance; NAS) | 210 | N/A in May |
Medicines licence applications through the International Recognition Procedure
| Key Performance Indicator (KPI) | KPI Performance May 2025 | KPI Performance 2025/26 YTD |
|---|---|---|
| 4. We will determine 95% of medicines licence applications within 60 days via recognition Route A and within 110 days via Route B through the International Recognition Procedure (IRP). | 100% | 100% |
| Regulatory Service | Target (days) | Last month average (days) | Notes |
|---|---|---|---|
| Licensing applications: International Recognition Procedure (IRP) | |||
| Route A | 60 | 53 | |
| Route B | 110 | 99 |
National Variations
| Key Performance Indicator (KPI) | KPI Performance May 2025 | KPI Performance 2025/26 YTD |
|---|---|---|
| 5. We will determine 95% of all national variations within their category’s statutory timeline. | 98% | 97% |
| Regulatory Service | Target (days) | Last month average (days) |
|---|---|---|
| National Variations | ||
| Type 1b | 30 | 18 |
| Type 2 | 90 | 41 |
| Safety Variations | ||
| Type 1b | 30 | 20 |
| Type 2 | 90 | 39 |
Manufacturing and distribution authorisations
| Key Performance Indicator (KPI) | KPI Performance May 2025 | KPI Performance 2025/26 YTD |
|---|---|---|
| 6. We will grant, vary or refuse 95% of manufacturing and distribution authorisations within their category’s statutory timeline. | 99% | 97% |
| Regulatory Service | Target (days) | Last month average (days) | Notes |
|---|---|---|---|
| Wholesale Dealer Licences | Target timescales vary dependant on whether an inspection is required or not. | ||
| New Application | 90 | 68 | |
| Variation: Inspection | 90 | 46 | |
| Variation: No Inspection | 30 | 11 | |
| Manufacturing Licences | Target timescales vary dependant on whether an inspection is required or not. | ||
| New Application | 90 | 44 | |
| Variation: Inspection | 90 | 29 | |
| Variation: No Inspection | 30 | 11 |
Reports of Adverse Incidents
| Key Performance Indicator (KPI) | KPI Performance May 2025 | KPI Performance 2025/26 YTD |
|---|---|---|
| 7. We will process 90% of all UK initial spontaneous Reports of Adverse Incidents related to healthcare products within 24 hours. | 94% | 95% |
| Regulatory Service | Notes | |||
|---|---|---|---|---|
| Adverse Reaction Reviews (combined medicines and devices) | Register for safety alerts from MHRA. |
Scientific advice
| Key Performance Indicator (KPI) | KPI Performance May 2025 | KPI Performance 2025/26 YTD |
|---|---|---|
| 8. (a) We will offer scientific advice to 95% of requests within 10 days of the request being made. | 57% | 32% |
| (b) We will deliver the formal written advice for 95% of requests within 30 days of the meeting date or, if no meeting is required or requested, within 30 days of receiving company documentation. | 70% | 39% |
| Regulatory Service | Target (days) | Last month average (days) | Notes |
|---|---|---|---|
| Scientific Advice | Find out about our work to overhaul the Scientific Advice service at MHRA. |
(a) Meeting Date Offered
| Regulatory Service | Target (working days) | Last month average (working days) |
|---|---|---|
| Clinical Trials | 10 | 17 |
| New Active Substance | 10 | 43 |
| Population Health | 10 | 9 |
| Biologicals | 10 | 26 |
| PIQs | 10 | N/A |
(b) Written Advice Delivered
| Regulatory Service | Target (working days) | Last month average (working days) |
|---|---|---|
| Clinical Trials | 30 | 29 |
| New Active Substance | 30 | 53 |
| Population Health | 30 | 25 |
| Biologicals | 30 | 18 |
| PIQs | 30 | N/A |