The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched a pilot for the Accelerated Aligned Pathway on October 10, 2025, six months ahead of the original April 2026 schedule. This initiative invites early adopters—pharmaceutical companies developing qualifying innovative medicines—to test a streamlined process that synchronize MHRA licensing decisions with NICE value assessments. By eliminating the traditional 90-day gap between marketing authorization and NICE guidance, the pilot aims to accelerate patient access to new treatments by 3–6 months, enhancing efficiency for the NHS and supporting the UK’s life sciences sector. The program builds on the March 2025 Regulatory Action Plan and responds to user research calling for tighter alignment in regulatory and health technology assessment (HTA) processes.
Background and Objectives
The UK’s regulatory landscape has evolved post-Brexit to prioritize speed and innovation, with MHRA focusing on safe, effective medicines licensing and NICE evaluating clinical and economic value for NHS adoption. Historically, sequential processes — MHRA approval followed by NICE appraisal — created delays, sometimes extending beyond 90 days and hindering timely market entry. The Accelerated Aligned Pathway addresses this by integrating the two stages, allowing parallel workflows under a joint information-sharing agreement.
Key objectives include:
- Reducing administrative burdens and timelines for industry, aligning with the government’s goal to cut business costs by 25% through smarter regulation.
- Ensuring faster NHS availability of breakthrough therapies, particularly for unmet needs in areas like oncology or rare diseases.
- Gathering real-world feedback from early adopters to refine the full rollout, including a new integrated joint scientific advice service by April 2026. This single-entry-point service will offer coordinated pre-market guidance on evidence requirements, helping developers align regulatory dossiers with HTA needs from the outset.
The pilot emerges from extensive stakeholder consultations (2023–2025) and complements broader reforms, such as the MHRA’s Innovative Licensing and Access Pathway (ILAP), which welcomed its first investigational products on October 14, 2025. MHRA Chief Executive Lawrence Tallon emphasized: “This new joint approach… will create a faster and more efficient regulatory system, designed to accelerate UK market entry and deliver innovative, life-changing treatments to NHS patients faster.”
NICE Chief Executive Dr. Sam Roberts added: “This joint working with our partners at the MHRA will allow us to accelerate medicines into the NHS even further to help transform the health of the nation.”
Key Features of the Pilot
- Eligibility Criteria: Open to companies with scheduled NICE technology appraisals for innovative medicines designated for “early access” under MHRA criteria (e.g., addressing significant unmet needs with promising benefit-risk profiles). Products must be in late-stage development or nearing submission; drug-device combinations may qualify if they fit ILAP alignments.
- Process and Timelines: Participants register early via a joint portal, enabling parallel submissions. MHRA and NICE conduct synchronized reviews, culminating in simultaneous publication of licensing and guidance decisions. The pilot runs through 2026, with automatic approvals targeted within standard MHRA timelines (e.g., 150 days for new active substances) minus the 90-day lag. A dedicated joint scientific advice mechanism launches by April 2026, offering confidential briefings on trial design, real-world evidence (RWE), and economic modeling.
- Support Mechanisms: Includes priority scheduling for appraisals, enhanced transparency on evidence gaps, and NHS England integration for adoption planning. Participants benefit from a single point of contact, reducing duplicate data requests.
| Feature | Description | Timeline/Benefit |
|---|---|---|
| Parallel Decision-Making | MHRA licensing and NICE HTA run concurrently under shared data protocols. | Eliminates 90-day gap; decisions published same day. |
| Joint Scientific Advice | Single-entry service for aligned regulatory/HTA input. | Launches April 2026; cuts delays in evidence planning by 20–30%. |
| Early Registration | Companies with scheduled appraisals contact NICE for suitability check. | Open now; pilot feedback shapes full program. |
| NHS Integration | Guidance on adoption barriers and uptake strategies. | Supports 3–6 month faster patient access. |
Procedural and Submission Updates
To join, companies with ongoing NICE appraisals should email scheduling@nice.org.uk to assess eligibility, providing details on the product’s innovation status and alignment potential. Successful early adopters will enter a structured pilot cohort, with MHRA/NICE assigning joint case managers. Submissions use existing platforms (e.g., MHRA’s eCTD for licensing, NICE’s appraisal templates), but with harmonized templates to streamline “present/proposed” data. The pilot includes quarterly feedback loops and a post-pilot evaluation in mid-2026.
For broader ILAP entry (related pathway for pre-confirmatory trials), applications remain open worldwide via the MHRA website, requiring an Innovation Passport application form.
Implications for Sponsors and Industry
This pilot is a game-changer for biotechs and pharma firms, potentially shortening time-to-market and boosting ROI on R&D—critical in a competitive global landscape where the UK trails EU/EMA hubs on speed. Sponsors gain predictability: earlier joint advice minimizes resubmissions (e.g., aligning RWE for HTA), while simultaneous decisions reduce revenue ramps from delayed reimbursements. For the NHS, it means quicker integration of high-value innovations, easing pressures in high-need areas and supporting the 10-Year Health Plan’s efficiency goals.
However, success hinges on proactive preparation — firms must audit dossiers for dual regulatory/HTA fit and invest in early engagement. Non-participation risks sticking with legacy delays, especially as full rollout mandates alignment. Internationally, it enhances the UK’s appeal for multinational filings, bridging to EMA’s PRIME scheme. Early estimates suggest 20–30% more medicines could reach patients annually, per government projections. For full details, refer to the MHRA’s announcement and joint MHRA-NICE blog. This summary reflects official positions as of October 16, 2025; sponsors should monitor GOV.UK for pilot updates and webinar recordings (e.g., the October 1 session on aligned decisions).
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