The MHRA has today published guidance on a Phase 1, 14-day pilot programme for clinical trials.
Below is an attempt to present the information in a Q&A format. To read the complete guidance, visit this MHRA page.
Which trials does this pilot apply to?
It applies to certain low-risk Phase 1 trials.
Why has this accelerated pathway been introduced?
This accelerated pathway was introduced in response to stakeholder and government calls for faster clinical trial start-ups, while using a controlled, evidence-based approach to maintain high safety and quality standards.
What does this pilot aim to achieve?
The pilot is a targeted MHRA initiative to speed up approvals for certain low-risk Phase 1 trials
The pilot aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
What does this pilot mean for the competitiveness of the UK in early phase research?
By piloting a two-week assessment timeline for suitable trials, the MHRA seeks to boost the UK’s competitiveness in early-phase research and encourage sponsors to run more Phase 1 studies in the UK.
How will the 14 calendar day timeline for the pilot be implemented?
Rather than an immediate change, the 14-day timeline is being phased in gradually throughout 2026.
From 30 March 2026, the target for MHRA’s first review was 28 days; this was shortened to 21 days from 29 June 2026 and will continue to reduce first review timeframes in stages to 18 days from 28 September 2026 and 14 days from 28 December 2026 (see table below)
| Date | First review time in no of calendar days |
|---|---|
| From 30 Mar 2026 | 28 calendar days |
| from 29 Jun 2026 | 21 calendar days |
| From 28 Sept 2026 | 18 calendar days |
| From 28 Dec 2026 | 14 calendar days |
Why is there the need for a progessive roll-out of the pilot?
This progressive roll-out allows MHRA teams to safely expand capacity and refine processes at each stage, ensuring the expedited timeline is delivered reliably.
What is the scope of the pilot?
The pilot’s scope is also limited to specific trials (see Table 1: Eligibility Inclusion/Exclusion Criteria).
What is the available capacity for the roll-out of the pilot?
Capacity will be tightly controlled, with only a small number of fast-track slots available each quarter .
This controlled approach ensures the MHRA can meet the commitment to reduced assessment timeframes with a high degree of predictability.
| 2026 period | First review time in no of calendar days | Maximum booking slots | Approximate pilot clinical trials applications per month |
|---|---|---|---|
| Q1 2026 Pilot launch | 28 calendar days | 1 per week | Up to 4 a month |
| End of Q2 2026 | 21 calendar days | 2 per week | Up to 8 a month |
| End of Q3 2026 | 18 calendar days | 3 per week | Up to 12 a month |
| End of Q4 2026 | 14 calendar days | 4 per week | Up to 16 a month |
- During each quarter of the pilot, the MHRA will accept a limited number of Phase 1 pilot applications per week.
- By Q4 2026, up to four pilot clinical trial applications (CTA) per week may be fast-tracked, each with a 14-day first review timeline.
- These numbers are maximum targets, not guaranteed availability.
What happens in case the pilot slots for a given week or quarter are already full?
If the pilot slots for a given week or quarter are already full, additional applications (or those that are ineligible) will proceed under standard timelines (30-day review) so that the constraints of the pilot do not impact the wider cohort of trials.
Does the pilot operate on a first-come, first-served basis?
Yes, the pilot operates on a first-come, first-served basis within these volume limits. Sponsors interested in utilising the 14-day pathway should plan accordingly.
About the validation period for each application for the pilot
Since the implementation of the new clinical trial regulations on 28 April 2026, the CTA application timelines include a validation period (of up to 7 calendar days).
- As for regular CTAs, the validation letter is sent automatically to confirm the start of the assessment timeline.
- It is from this time that the 14-day review target is calculated. In practice, a 14-day review target means roughly two weeks from the completion of validation to a decision.
- Predictability is a key goal e.g. if your application passes pilot validation on a Monday (Day 0), you can expect to receive the MHRA’s initial decision by about Monday two weeks later (Day 14).
What is the Submission, validation, and assessment process?
To successfully book a fast-track 14-day assessment slot in the pilot, sponsors must complete a series of key steps (see below) in order. Below is the critical path, highlighting each essential step and its dependencies.
- Each step must be completed in sequence for a successful booking. In particular, securing a slot depends on proactive early communication with the MHRA and strict adherence to the agreed submission timing.
- Any delay in submission or an incomplete application could remove the trial from the fast-track queue.
- Likewise, MHRA’s validation within 1 business day is crucial to kick off the 14-day assessment window on schedule.
- By following the above steps closely, and paying attention to capacity limits and timing guidelines, sponsors can confidently navigate the booking process and set their Phase 1 trial on the path to a swift 14-day initial MHRA decision.
Step 1: Confirm eligibility
Ensure your trial meets all inclusion criteria and that no exclusion criteria apply. Use the Phase 1 Pilot Eligibility checklist to self-assess your study.
- You should be able to answer ‘yes’ to every inclusion criteria, and ‘no’ to all exclusion criteria before proceeding.
- If the trial does not fully qualify, it cannot be booked onto the reduced timetable and will instead follow the standard 30-day review timeline.
Step 2: Pre-Submission planning
Prepare all required CTA documents and agree internally a target submission date for CTA.
- Contact HRA to request a fast-track ethics review; identify suitable REC dates that match your planned submission window.
- HRA fast-track ethics review process has specific deadlines and turnaround times that must be taken into consideration within your internal timeline.
- Aligning your approach in this way will ensure that MHRA expedited assessment does not complete only for a delay to be caused to the study by an outstanding ethics decision.
Step 3: Notify the MHRA and book a Slot
You should contact the us via Phase1Pilot-Booking@MHRA.gov.uk to request a slot for your upcoming Phase 1 application, in sync with any HRA fast-track ethics review date(s).
- Provide the following key details:
- trial title
- IRAS Number
- Name of P1A
- Sponsor Name
- contact details
- REC date(s)
- confirmation of eligibility, and your intended submission date.
- Pilot capacity is strictly limited, and slots are allocated on a first come, first served basis.
- Advance booking is advised; early notification allows the MHRA to book in your submission and helps avoid your trial being turned away or delayed due to a full schedule
Step 4: Booking confirmation
The MHRA will respond to the booking request, either to confirm the slot, or suggest an alternative if the requested timing isn’t available.
- This confirmation secures your place in the pilot queue for the agreed week, and you will be given details of the booking slot and reference number.
- Internally, the MHRA will coordinate its assessment teams and operations to be ready for your submission during that slot.
- If no slot is available when you first enquire, you may choose to delay your submission or proceed under the standard timeline.
- Once you have a confirmed slot, you can finalise your application and proceed to CTA submission.
Step 5: Submit the CTA
On the scheduled date, submit your CTA via IRAS as usual, with email confirmation of submission to Phase1Pilot-Booking@MHRA.gov.uk.
- In your cover letter, you must clearly state that this is a Phase 1 expedited application and include the completed pilot eligibility checklist, along with the reference number given to you with your booking confirmation.
- Ensure that you provide one email address for the point of contact, so that the MHRA can keep in touch during the pilot process.
- If possible, the CTA should be submitted as early as possible during your week-long slot.
Step 6: Validation process (Day 0)
Validation checks will be carried out, to ensure all required documentation has been submitted and that these are openable and legible.
- If the application is not valid, you will receive notification that this has been invalidated.
- Where there is still time remaining in your booked week, you will be able to resubmit; however, if your application is invalidated on the last business day of this slot, you will not be able to resubmit and will lose your expedited assessment booking.
- Once validated, your application will proceed through internal processes for assessment.
What are the expected benefits for sponsors?
Sponsors whose trials are accepted into the pilot can expect several important benefits:
- Faster Approvals:
- The MHRAs goal is to provide the initial regulatory decision (first review outcome) in 14 days by 28 December 2026.
- Even during the early pilot stages, the first-round review will be significantly quicker than the standard 30 days.
- Greater Predictability:
- The pilot places a strong emphasis on predictability and reliability of timelines.
- If your application passes validation and enters the 14-day pathway, you can have high confidence that a “Day 14” decision will be reached.
- This consistency helps with planning downstream activities and provides assurance to sponsors and CROs that regulatory turnaround will be prompt and on schedule.
- Enhanced Regulatory Support:
- By focusing on trials in well characterised settings (healthy volunteers, accredited units) with good existing data, the MHRA can streamline its review without compromising quality.
- Sponsors will still receive the full rigor of scientific and ethical review, but in a shorter timeframe.
- The MHRA is dedicating specific resources and optimising internal workflows to ensure pilot submissions are handled efficiently.
Further information and resources
These are available at the link below.
Source: MHRA