Overview
Our 2025/26 business plan reaffirms MHRA’s commitment to delivering excellent services and maintaining predictable, reliable performance for our customers. It outlines our key performance indicators (KPIs) and sets a corporate objective to improve the transparency, clarity, and accessibility of our performance information.
In line with this commitment, we are transitioning to reporting median timelines rather than mean (average) timelines. This change will improve the usefulness of our data for applicants and strengthen accountability across our services.
Below, we provide MHRA’s performance data for December 2025 for each KPI in this new format.
From December 2025 onwards, we will present performance timelines using the median rather than the mean. We are making these changes following continuous review of our performance data publication, to align with best practice for reporting service performance in areas where case durations can naturally vary.
The median gives a more accurate picture of a typical customer experience. It provides a clearer, fairer assessment of operational performance, and supports more informed planning and decision-making for applicants.
We continue to publish each KPI in full, including the percentage delivered in the last month and year‑to‑date (YTD) data where available. Our current reporting year began on 1 April 2025, and all YTD data reflects this timeframe.
We provide the target timeline for each regulatory function, alongside the median processing timeline. Additional context is included to direct applicants to other useful sources of information.
For insight into how our performance compares across the wider UK regulatory system, applicants can refer to the cross‑government Regulator Dashboard, which is updated quarterly.
Clinical Trial Authorisation (CTA) and Clinical Investigation applications
| Key Performance Indicator (KPI) |
KPI Performance December 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 median (days) |
Notes |
| Initials |
30 |
29 |
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 |
33 |
|
Clinical Investigations
| Regulatory Service |
Target (days) |
Last month median (days) |
| Initials |
60 |
55 |
| Amendments |
21 |
8 |
Vaccine batches and blood product batches
| Key Performance Indicator (KPI) |
KPI Performance December 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% |
100% |
| Regulatory Service |
Target (days) |
Last month median (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 |
2 |
|
| Blood Products |
15 |
4 |
|
Medicines licence applications via the national route
| Key Performance Indicator (KPI) |
KPI Performance December 2025 |
KPI Performance 2025/26 YTD |
| 3. We will determine 95% of medicines licence applications within 210 days via the national route. |
97% |
99% |
Medicines licence applications through the International Recognition Procedure
| Key Performance Indicator (KPI) |
KPI Performance December 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% |
99% |
| Regulatory Service |
Target (days) |
Last month median (days) |
Notes |
| Licensing applications: International Recognition Procedure (IRP) |
|
|
|
| Route A |
60 |
59 |
|
| Route B |
110 |
96 |
|
National Variations
| Key Performance Indicator (KPI) |
KPI Performance December 2025 |
KPI Performance 2025/26 YTD |
| 5. We will determine 95% of all national variations within their category’s statutory timeline. |
97% |
97% |
| Regulatory Service |
Target (days) |
Last month median (days) |
| National variations |
|
|
| Type 1b |
30 |
14 |
| Type 2 |
90 |
53 |
| Safety variations |
|
|
| Type 1b |
30 |
15 |
| Type 2 |
90 |
55 |
Manufacturing and distribution authorisations
| Key Performance Indicator (KPI) |
KPI Performance December 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. |
98% |
97% |
| Regulatory Service |
Target (days) |
Last month mean (days) |
Notes |
| Wholesale Dealer Licences |
|
|
Target timescales vary dependant on whether an inspection is required or not. |
| New Application |
90 |
50 |
|
| Variation: Inspection |
90 |
40 |
|
| Variation: No Inspection |
30 |
12 |
|
| Manufacturing Licences |
|
|
Target timescales vary dependant on whether an inspection is required or not. |
| New Application |
90 |
55 |
|
| Variation: Inspection |
90 |
46 |
|
| Variation: No Inspection |
30 |
15 |
|
Reports of Adverse Incidents
| Key Performance Indicator (KPI) |
KPI Performance December 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. |
97% |
96% |
Scientific advice
| Key Performance Indicator (KPI) |
KPI Performance December 2025 |
KPI Performance 2025/26 YTD |
8. (a) We will offer a meeting date for 95% of scientific advice requests within 10 working days of submission.
*In line with MHRA scientific advice guidance, the 10 working day period starts when MHRA has received a complete list of questions.
|
100% |
69% |
| (b) We will deliver the formal written advice for 95% of requests within 30 working days of the meeting date or, if no meeting is required or requested, within 30 working days of receiving company documentation. |
85% |
44% |
(a) Meeting Date Offered
| Regulatory Service |
Target (working days) |
Last month median (working days) |
| Average over all regulatory services |
10 |
3 |
| Clinical Trials |
10 |
1 |
| New Active Substance |
10 |
3 |
| Established Medicines |
10 |
4 |
| Biologicals |
10 |
5 |
| PIQs |
10 |
3 |
(b) Written Advice Delivered
| Regulatory Service |
Target (working days) |
Last month median (working days) |
| Average over all regulatory services |
30 |
21 |
| Clinical Trials |
30 |
26 |
| New Active Substance |
30 |
20 |
| Established Medicines |
30 |
22 |
| Biologicals |
30 |
20 |
| PIQs |
30 |
N/A |
