New MHRA/NICE Collaboration – What’s it all about and why is it important?
The UK’s New Era of Regulatory & HTA (Health Technology Assessment) Alignment: What Global Pharma Needs to Know
The UK is entering a new phase of innovation in how it regulates, assesses, and adopts new medicines—and it’s a development the global pharmaceutical and biopharmaceutical industry cannot afford to overlook.
Earlier this year, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) issued an open letter outlining a transformational shift in how they will collaborate to accelerate patient access to new therapies. This coordinated effort promises significant opportunities for pharma and biotech companies seeking streamlined access to one of the world’s most influential healthcare markets.
PCL see this move as a strategic inflection point for UK launches—and a model that could influence broader global HTA alignment.
Why the UK Market Matters More Than Ever
The UK’s healthcare system is unique: a single national provider (the NHS) serves over 65 million people, funded by taxpayers. When you secure a positive NICE recommendation, the NHS is mandated to make your product available within 90 days. This provides one of the most predictable and transparent market access pathways in the world.
Furthermore, NICE guidance is globally referenced by many other markets. So a strong UK launch can provide downstream advantages internationally—from accelerating HTA decisions in other countries to bolstering investor and payer confidence.
What’s Changing in 2025: A Closer Look
In March 2025, the UK Government reaffirmed its commitment to deeper collaboration between MHRA and NICE. Here’s what’s on the table:
✅ Integrated Scientific Advice
A refreshed joint advice service between MHRA and NICE will provide coordinated feedback to developers earlier in the product lifecycle. This will support more efficient trial design, evidence generation, and alignment of regulatory and HTA expectations.
✅ Aligned Timelines for Regulatory Approval and HTA Guidance
Developers who opt-in to collaborative information sharing between MHRA and NICE will benefit from:
- Concurrent MHRA and NICE reviews
- Priority scheduling by NICE committees
- Earlier publication of HTA guidance, reducing time to NHS access
This represents a true paradigm shift: for eligible products following optimal timelines, NICE guidance may be published at or near the time of MHRA marketing authorisation—a game-changer in patient access timelines.
✅ Flexible Process for Complex Products
Not all products will be eligible for pre-authorisation NICE engagement. In these cases, a fallback process will apply, with NICE reviews beginning post-approval. Draft process flows and full guidance will be made available soon.
Key Requirement: UK PharmaScan
One message from the regulators is loud and clear: if you want to benefit from aligned review and early access in the UK, UK PharmaScan is non-negotiable.
You must:
- Register your product at least 3 years before expected MA
- Provide timely, comprehensive updates
- Use UK PharmaScan irrespective of your regulatory route with the MHRA
This tool enables MHRA and NICE to plan capacity and timelines, reducing delays to NHS access. Failure to register early may jeopardize your eligibility for concurrent review pathways.
What You Should Do Now
If you’re planning a UK launch—or even considering one—there are clear next steps to position your asset for success:
- Register early on UK PharmaScan.
- Engage MHRA and NICE through their advisory services.
- MHRA offers a fee-based Scientific Advice service, with waivers for UK-based SMEs.
- NICE Advice supports pre-evaluation readiness, including fee-based services for strategy, evidence planning, and more.
- Opt-in to collaborative information sharing between MHRA and NICE when available.
- Join the webinar on 1 October 2025 to learn more about the process changes (registration details forthcoming).
Strategic Implications for Pharma and Biotech
This collaborative approach reinforces the UK’s ambition to be an early launch market of choice—particularly for innovative medicines, rare diseases, and advanced therapies.
For global companies, this is a moment to rethink launch sequencing. The UK may now serve as a more attractive first-wave market, offering:
- Rapid time to patient access
- High-value HTA endorsements
- Strong signal value to other global markets
But this requires strategic foresight, early planning, and timely engagement.
Final Thoughts
The UK is raising the bar on how regulatory and HTA bodies can work together to serve patients, accelerate innovation, and reduce market access friction. For those who act early and smartly, the UK may be the launchpad your product needs.