Scientific Advice in the UK

Our UK team supports scientific advice interactions with the MHRA, including formal Scientific Advice, Innovation Office engagement, and pre-submission meetings. The UK operates its own scientific advice framework independently of the EMA, with distinct procedures, timelines, and areas of focus. For the full description of our scientific advice methodology across all authorities (EMA, FDA, national competent authorities), see Regulatory Strategy & Operations.

UK Regulatory Landscape

The MHRA provides several routes for early regulatory engagement, each with different scope and formality.

MHRA Scientific Advice

Formal scientific advice from the MHRA allows sponsors to obtain input on key development questions before committing to pivotal studies or submissions. Topics typically include clinical trial design, endpoint selection, CMC strategy, nonclinical requirements, and the overall regulatory pathway for UK authorisation. The MHRA publishes guidance on how to request scientific advice and the expected format for briefing documents. Timelines are generally faster than EMA Scientific Advice.

MHRA Innovation Office

The Innovation Office provides early, informal regulatory guidance for innovative products, novel technologies, and products that do not fit neatly into established regulatory categories. This includes advanced therapies, AI-based products, novel drug-device combinations, and products at regulatory boundaries. The Innovation Office is a lower-barrier entry point than formal scientific advice and is particularly useful for early-stage companies or novel product types.

UK Integrated Scientific Advice

For products where alignment between the regulator and HTA body matters, the MHRA and NICE can provide coordinated scientific advice, covering both regulatory and health technology assessment considerations in a streamlined process.

What We Handle Locally

Our UK team delivers the following within the UK scientific advice and regulatory engagement framework. For our full scientific advice methodology across EMA, FDA, and national competent authorities, see the central Regulatory Strategy & Operations page.

  • Plan and manage MHRA Scientific Advice requests: identify the right timing, frame questions specific to UK regulatory expectations, and prepare briefing packages that reflect MHRA formatting and content preferences.
  • Support MHRA Innovation Office engagement for novel or borderline products. Prepare the initial enquiry, coordinate the meeting, and translate Innovation Office feedback into actionable development decisions.
  • Coordinate UK Integrated scientific advice with MHRA and NICE, aligning regulatory and HTA questions into a single coherent package.
  • Prepare UK-specific briefing documentation where the MHRA’s expectations differ from EMA or FDA requirements. This includes adapting cross-regional briefing packages for UK-specific questions or producing standalone MHRA briefing books.
  • Manage meeting logistics, team preparation (including mock Q&A sessions focused on MHRA questioning style), and post-meeting follow-up. Review MHRA meeting minutes to identify UK-specific commitments and their implications for the development plan.
  • Integrate MHRA scientific advice outcomes with advice obtained from EMA, FDA, or other authorities. Where positions diverge across jurisdictions, we assess the implications and recommend strategies to reconcile them without duplicating evidence generation.

Our UK Team

MHRA scientific advice interactions are managed by our Regenold UK regulatory team, with senior regulatory strategists leading the question framing and briefing document preparation. For cross-regional SA coordination (EMA, FDA, national CA), the UK team works with our central regulatory strategy specialists.

For the full team, see Our Teams.

Planning MHRA engagement?

Tell us about your product and what development questions you need answered. We will advise on the right route and prepare the briefing.

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Frequently Asked Questions (FAQ)

When should we seek MHRA Scientific Advice rather than relying on EMA advice?

If you are planning a UK-specific submission route (national procedure, IRP, ILAP), MHRA-specific advice is essential because EMA advice does not bind or formally inform MHRA assessment. Even for products going through parallel EU and UK routes, MHRA advice is valuable where UK-specific requirements may differ, such as post-Brexit divergence on guidelines or assessment expectations.

What is the difference between the Innovation Office and formal Scientific Advice?

The Innovation Office provides early, informal guidance suited to novel products or unclear regulatory classifications. It is faster, lower-cost, and does not require a formal briefing book. Formal Scientific Advice is a structured procedure with a written briefing document, defined questions, and formal written minutes. Use the Innovation Office early to clarify the pathway; use formal Scientific Advice before committing to pivotal development decisions.

Can we use the same briefing book for MHRA and EMA?

Core content can be shared, but the framing often needs adaptation. MHRA may have different priorities or focus areas compared to EMA assessors. We adapt cross-regional briefing packages to address MHRA-specific questions and UK regulatory context while maintaining consistency with the overall development strategy.

How does MHRA-NICE Integrated Scientific Advice work?

The MHRA and NICE Integrated Scientific Advice service is a coordinated process where regulatory and HTA questions are addressed together. This is particularly valuable for products where evidence generation needs to satisfy both regulatory approval and HTA assessment for reimbursement. We prepare an aligned question set and briefing document that serves both bodies, and manage the aligned meeting process.

Do you run clinical trials directly, or do you manage CROs?

We do not operate our own trial sites or in-house labs. When a trial needs operational execution (site monitoring, data management, biostatistics, central lab services), we select, qualify, and manage CROs and service providers. We write the RFPs, evaluate bids, negotiate contracts, and provide oversight. What we do directly: programme design, protocol authoring, regulatory submissions, sponsor representation, authority interactions, and clinical dossier compilation.