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MHRA Scientific Advice: A Strategic Asset for Regulatory Success

  • Writer: Jackie Roberts
    Jackie Roberts
  • Jul 22
  • 2 min read

In today’s fast-paced regulatory landscape, clarity is power. Whether you're developing a novel therapy, navigating post-Brexit complexities, or preparing for inspection, one of the most underutilized strategic tools, and one worth engaging with, is MHRA Scientific Advice. As both the founder of PharmaGuard Consultancy Ltd and an experienced industry professional, I’ve seen firsthand how early engagement with regulators can transform uncertainty into opportunity. MHRA Scientific Advice isn’t just a procedural step—it’s a chance to co-create your development pathway with the very people who will assess it.

MHRA Scientific Advice allows sponsors—pharma companies, biotech innovators, and academic researchers—to seek formal guidance on the scientific and regulatory aspects of their development programs. Topics are varied and can include:

  • Clinical trial design and endpoints

  • Non-clinical study requirements

  • Quality and manufacturing considerations

  • Pharmacovigilance planning

  • Device-drug combinations and borderline products

The advice is non-binding, but it offers invaluable clarity—especially in a post-Brexit regulatory environment where UK-specific expectations may differ from EU norms. This is important because engaging with MHRA early can help you:  De-risk your development strategy;  Accelerate timelines by clarifying expectations;  Align your plans with UK regulatory standards and support innovation, especially for ATMPs, digital health, and AI-driven products

For organisations which meet the requirements of being classified as a small/medium enterprise (SME), the MHRA offers fee reductions and tailored support—recognizing the unique challenges faced by emerging innovators and small businesses.

As well as addressing regulatory and clinical questions for those of us working in pharmacovigilance and safety governance, MHRA Scientific Advice can shape robust safety strategies. It’s particularly useful for: Signal detection methodologies; Risk management plans (RMPs); Post-authorisation safety studies (PASS) and AI-enhanced safety systems and data analytics. This is especially relevant in due diligence scenarios, where clarity on safety expectations can influence acquisition decisions and inspection resilience.

If you're considering MHRA Scientific Advice, here are a few tips to maximize its value:

  • Be Specific: Vague questions yield vague answers. Frame your queries with precision.

  • Engage Early: Advice is most powerful when it shapes your strategy—not when it confirms it.

  • Document Decisions: Keep a clear record of advice received and how it informed your development.

  • Integrate Feedback: Use MHRA input to refine your regulatory roadmap, not just tick a box.

Since the UK’s departure from the EU, MHRA Scientific Advice has become even more critical. It offers a distinct regulatory lens—one that complements, but doesn’t duplicate, EMA guidance. Sponsors must now treat MHRA input as a standalone strategic asset. Scientific Advice service from the MHRA is more than just a service—it’s a conversation. A chance to align, adapt, and advance with confidence. For consultants, developers, and governance leaders alike, it’s a tool that turns complexity into clarity.

If you’re navigating regulatory uncertainty or preparing for inspection, let’s talk. At PharmaGuard, we specialize in turning advice into action—and strategy into success.

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