14-day assessment stepwise implementation programme for Phase 1 clinical trials
Updated 30 September 2026
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Introduction
At the end of March 2026, we launched the MHRA 14-day assessment stepwise implementation programme; a progressive roll-out of the 14-day assessment timeline for Phase 1 healthy volunteer clinical trial applications in the UK, with a view to delivering against our commitments to do so, by the end of March 2027.
The stepwise implementation programme gradually reduces the first cycle of MHRA review time from the standard 30 days to 14 days over the course of 2026, for trials that meet the set criteria.
Sponsors of qualifying studies can benefit from faster approval decisions, provided they meet all eligibility criteria and follow the defined process, which includes pre-booking as places will be limited and clearly documenting inclusion and exclusion criteria on covering letters.
The goal is to accelerate early phase trials without compromising safety or quality, making the UK more attractive for Phase 1 research.
Overview of the stepwise implementation programme and its purpose
The stepwise implementation programme is a targeted MHRA initiative to speed up approvals for certain low-risk Phase 1 trials. The progressive rollout aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
This accelerated programme 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.
By implementing 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.
Progressive roll-out
Rather than an immediate change, the 14-day timeline is being phased in gradually throughout 2026. From 30 March 2026, the target for the MHRA’s first review was 28 days; this was shortened to 21 days from 29 June 2026, 18 days from 28 September 2026 and will continue to reduce first review timeframes to 14 days from 28 December 2026.
This progressive roll-out allows MHRA teams to safely expand capacity and refine processes at each stage, ensuring the expedited timeline is delivered reliably.
Capacity will be tightly controlled, with only a small number of fast-track slots available each quarter (see the 2026 Timeline table below). The stepwise implementation programme’s scope is also limited to specific trials (see Table 1: Eligibility Inclusion/Exclusion Criteria). This controlled approach ensures the MHRA can meet the commitment to reduce assessment timeframes with a high degree of predictability.
Stepwise implementation programme scope
The implementation programme is restricted to Phase 1 trials involving primarily healthy adult volunteers in the UK. The programme is not open to all Phase 1 trials, and no exceptions outside the defined criteria will be made.
Eligibility criteria for fast-track review
To qualify for the 14-day assessment stepwise implementation programme, a clinical trial application must meet all inclusion criteria and have none of the exclusion factors listed below. In other words, the trial must be a straightforward, low risk Phase 1 study in healthy volunteers, with substantial existing safety data.
Sponsors are responsible for self-assessing eligibility before submission and should clearly confirm how each criterion is met in the cover letter, enclosing an eligibility checklist or table for clarity. If any single inclusion criterion is not met, or any exclusion applies, the application will not be accepted into the 14-day stepwise implementation programme and will revert to standard timelines.
Table 1: Eligibility Inclusion/Exclusion Criteria
| Inclusion Criteria (all must be true) | Exclusion Criteria (if any apply, trial not eligible) |
|---|---|
| Phase 1 HVT (including BE, DDI, mass balance and QT studies) Or Phase 1 non-HVT, (non-oncology patients) where safety assessment is the primary objective | First-in-human (FIH) trial |
| Satisfactory prior clinical safety data | Phase 1 non-HVT where the study aims or objectives stretch to investigate the benefit of the treatment to subjects |
| All proposed doses demonstrated safety and tolerability in previous clinical studies | Advanced Therapy IMPs (ATIMPs) |
| No major safety signals in previous human exposure | Decentralised manufactured IMPs |
| Up to 3 active IMPs | More than one first-in-UK (FUK) drug substance |
| More than 3 active IMPs (excluding different strengths of the same look-alike/dose-weight proportional formulation) | |
| Involves a medical device, an in vitro diagnostic (IVD), or a companion diagnostic | |
| Requires referral to EAG/CHM | |
| Complex design, e.g. Basket, Umbrella or Platform (including MAMS) designs | |
| Pivotal nonclinical data not generated in GLP compliant facility in Organisation for Economic Co-operation and Development (OECD) MAD country | |
| IMP with complex pharmacology (e.g., novel mechanism, off-target effects) |
Note: Where a shortened assessment timetable is proposed, and where any of the products used in the trial have significantly complex design, manufacturing or controls, the agency may switch the CTA assessment from a shortened timetable to the standard timetable. This will be done at the agency discretion and without consultation with the sponsor/applicant.
Before applying, ensure the above criteria is used as a checklist. If your study fails any criterion or triggers any exclusion, it will not qualify for the 14-day fast track. Ineligible applications will be assessed under the standard timeframe (30 days) or may be rejected outright if they’re fundamentally unsuitable.
Clearly state your trial’s eligibility in the cover letter and include a filled ‘Phase 1, 14-Day Stepwise Implementation Programme Eligibility’ table with your submission. This helps the agency quickly identify the application as a programme candidate.
2026 Stepwise implementation programme timeline and capacity
The 14-Day Assessment stepwise implementation programme will run throughout 2026, with specific targets and limits each quarter. As the progressive implementation progresses, the MHRA will accept more applications into the fast-track, and the first review timeline will shorten, as shown in Table 2 below.
Table 2: Review Time vs. Application Throughput
| 2026 Period | First Review Target (MHRA initial decision) | Maximum booking slots | Approx. per month |
|---|---|---|---|
| 30 March 2026 (Programme Launch) | 28 calendar days | 1 per week | Up to 4 per month |
| 29 June 2026 | 21 calendar days | 2 per week | Up to 8 per month |
| 28 September 2026 | 18 calendar days | 3 per week | Up to 12 per month |
| 28 December 2026 | 14 calendar days | 4 per week | Up to 16 per month |
During each quarter of the progressive implementation programme, we will accept a limited number of Phase 1 applications per week.
From 28 December 2026, up to four clinical trial authorisation (CTA) applications per week may be fast-tracked, each with a 14-day first review timeline. These numbers are maximum targets, not guaranteed availability. If the available 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 programme do not impact the wider cohort of trials.
The stepwise implementation programme operates on a first-come, first-served basis within these volume limits. Sponsors interested in utilising the 14-day accelerated programme should plan accordingly (see next section).
The timeline clock for the purposes of the stepwise implementation programme refers to calendar days for the first assessment decision, not working day.
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 CTA applications, 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 validation on a Monday (Day 0), you can expect to receive the MHRA’s initial decision by about Monday two weeks later (Day 14).
Submission, validation, and assessment process
To benefit from the expedited timeline, sponsors need to follow the stepwise implementation programme process carefully.
The progressive implementation process has no extra intermediaries; once your application is validated and deemed eligible, it goes to assessment teams for review.
Applicants will not receive a separate “acceptance into stepwise implementation programme” notice beyond the usual validation confirmation. If you don’t hear from the MHRA immediately post submission, it means your application is likely proceeding in the stepwise implementation programme queue.
Applicants must ensure they submit high quality, complete documentation to avoid delays: the reduced timeframe leaves little room for clarifications during the review, so ensure your dossier is robust and addresses all regulatory requirements upfront. Incomplete or poor-quality submissions could undermine the success of the pilot and may be excluded from the fast-track.
Booking a slot on the Phase 1 stepwise implementation programme
To successfully book a fast-track 14-day assessment slot in the stepwise implementation programme, sponsors must complete a series of key steps 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, the 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 application documents and agree internally a target submission date for the CTA application.
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 Phase1StepwiseBooking@mhra.gov.uk to request a slot for your upcoming Phase 1 application, coordinated with any HRA fast-track ethics review date(s).
Provide key details (trial title, IRAS Number, Sponsor Name, contact details, REC date(s), confirmation of eligibility, and your intended submission date). Capacity for the stepwise implementation programme is strictly limited, and slots are allocated on a first come, first served basis.
Advance booking is advised; early notification allows us to book in your submission and helps avoid your trial being turned away or delayed due to a full schedule.
Step 4: Booking confirmation
We 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, we 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 CTA application and proceed to submission.
Step 5: Submit the CTA application
On the scheduled date, submit your CTA application via IRAS as usual, with email confirmation of submission to Phase1StepwiseBooking@mhra.gov.uk.
In your cover letter, you must clearly state that this is a “Phase 1 stepwise implementation programme application” and include the completed 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 we can keep in touch during the 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.
Expected benefits for sponsors
Sponsors whose trials are accepted into the stepwise implementation programme can expect several important benefits:
- Faster approvals: Our goal is to provide the initial regulatory decision (first review outcome) in 14 days by 28 December 2026. Even during the early stages of the progressive implementation, the first-round review will be significantly quicker than the standard 30 days.
- Greater predictability: The stepwise implementation programme 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. We are dedicating specific resources and optimising internal workflows to ensure pilot submissions are handled efficiently.
Further information and resources
For more details and support regarding the Phase 1 expedited assessment pilot, sponsors may refer to the following resources:
- HRA Guidance for fast-tract ethics review
- Clinical Trial Applications Guidance: General guidance, outside of the stepwise implementation programme, about preparing and submitting CTA applications in the UK (provides details on using IRAS, fees, documentation requirements and more).
- MHRA Clinical Trials Helpline: For questions about the pilot or to discuss potential submissions, you can contact the MHRA Clinical Trials Unit helpline at clintrialhelpline@mhra.gov.uk or by phone (020 3080 6456). They can assist with general enquiries and help you understand the pilot process, including slot availability and any upcoming schedule considerations.