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title: "Fortrea’s Intelligence Briefing: New Signals from the MHRA, NMPA and NAMs"
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What’s New This Month ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­    ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­  

| View in browser Regulatory authorities across the UK, China, Europe, and the United States are signalling a clear shift in how they expect drug development programs to be designed and executed. While the specific initiatives differ, the underlying direction is consistent: earlier engagement, greater regulatory involvement in development decisions, and increased emphasis on generating robust, decision-quality evidence from the outset. Alicia Baker McDowell Vice President and Head of Global Regulatory Consulting Whether through the MHRA's Innovation Accelerator, China's implementation of an operational drug trial data protection framework, or growing acceptance of New Approach Methodologies (NAMs), regulators are moving beyond their traditional role as reviewers of completed development programs. Increasingly, they are becoming active stakeholders in shaping development pathways. For sponsors, this reinforces the importance of proactive regulatory strategy, not simply as a mechanism for compliance, but as a critical lever for accelerating development, protecting innovation, reducing risk, and maximizing the value of evidence generated throughout the product lifecycle.    Stay in the loop. Subscribe to Fortrea's regulatory newsletter MHRA Innovation Accelerator: A signal that earlier regulatory engagement matters more than ever The launch of the MHRA Innovation Accelerator in July 2026 introduces a single, coordinated route for sponsors developing innovative medicines and technologies to access regulatory support. By bringing together multiple innovation support functions under one framework, the MHRA is aiming to reduce complexity and encourage earlier dialogue with developers.  Explore how the MHRA Innovation Accelerator could influence your development strategy China's drug trial data protection era begins China's National Medical Products Administration (NMPA) has introduced an operational drug trial data protection framework that may influence how sponsors think about regulatory exclusivity, asset value and development sequencing. The framework creates protection periods linked to innovation level and clinical value, signalling increased emphasis on protecting original evidence generation.    Why this matters:  Clinical trial data are increasingly being viewed as strategic assets rather than solely evidence for approval. Sponsors may need to assess data protection alongside patents, regulatory pathway, lifecycle planning and launch strategy when evaluating future investment decisions. The framework may also strengthen the rationale for earlier China participation in multi-regional development programmes.  Read a deeper dive on China's data protection framework and what it could mean for global development programmes New Approach Methodologies: Moving from possibility to implementation Regulatory discussion around New Approach Methodologies (NAMs) appears to be evolving. Recent activity from the FDA, EMA and UK MHRA suggests increasing focus on where human-relevant, non-animal approaches can be applied effectively within drug development and regulatory decision-making.    Why this matters: The opportunity is no longer simply reducing animal use. NAMs may offer sponsors enhanced human relevance, deeper mechanistic understanding and additional tools for evidence generation. However, regulatory acceptance remains context-specific, meaning sponsors should carefully assess where these approaches fit within broader development and regulatory strategies. The emergence of initiatives such as the EMA's draft qualification opinion on virtual control groups highlights how regulators are beginning to evaluate novel methodologies when supported by a clearly defined context of use and robust scientific evidence.  Explore how NAMs could fit into future evidence-generation strategies Preparing for a changing regulatory landscape? Across these developments, a common trend is emerging: regulators are placing greater emphasis on earlier engagement, stronger evidence strategies and more deliberate development planning. Discuss your development approach with Fortrea's regulatory consulting team and explore how evolving regulatory expectations may affect your programme strategy.  Connect with us for a more detailed briefing This is a marketing email sent to  EmailAddress Privacy Policy \| Unsubscribe \| UpdateYour Preferences Fortrea, 8 Moore Drive, Durham, NC 27709, USA. © 2026 Fortrea® Holdings. All Rights Reserved. |
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