By GARR Staff
July 15, 2025
In today’s fast-moving global health environment, regulatory decisions about medical products—drugs, diagnostics, and medical devices—can be a matter of life and death. But how do we make sure those decisions are timely, efficient, and evidence-based, without compromising safety?
The answer may lie in an underused but powerful concept: Regulatory Reliance.
🔍 What Is Regulatory Reliance?
Regulatory Reliance is when one regulatory authority uses or builds upon the work of another trusted authority to inform its own decision-making. It doesn’t mean rubber-stamping or outsourcing, but rather using validated evidence to accelerate approvals, especially for well-characterized products.
The WHO’s official guidance document TRS 1033 – Annex 10: Good Reliance Practices (2021) defines “reliance” and explains how national regulatory authorities (NRAs) may “take into account and give significant weight to assessments performed by another regulator or trusted institution” to avoid unnecessary duplication, optimize resources, and accelerate access to safe, effective, quality-assured medical products (WHO, 2021).
💡 Why Is Regulatory Reliance Important?
The U.S. Food and Drug Administration (FDA), especially in its device branch (CDRH), faces increasing strain due to rising technological complexity, staffing issues, and growing submission volume. Regulatory reliance could offer several benefits that may help in the U.S. and globally;
- Faster Access for Patients: Devices already deemed safe and effective in other countries like Canada, the EU, or Australia could reach Americans sooner.
- Efficiency for the FDA: Frees internal capacity for high-risk, novel products where the FDA’s independent evaluation is essential and needed.
- Stronger Global Coordination: Helps harmonize standards for global health crises, like pandemics.
🔄 Key Terms: What’s the Difference?
Let’s clarify how reliance compares to other commonly used concepts:
|
Term |
Definition |
Example |
Level of Integration |
|
Regulatory Reliance |
One regulator uses another’s assessment to inform its own decision |
TGA considers FDA’s assessment in its own review |
Moderate |
|
Regulatory Recognition |
One regulator formally accepts another’s decision or standard |
France incorporating EU MDR into its national legislation, meaning the EU declaration of conformity is the primary document for market access. |
High |
|
Regulatory Harmonization |
Alignment of technical standards, terminology, and procedures |
ISO Standards accepted across jurisdictions |
Structural |
|
Regulatory Convergence |
Independent regulators evolve toward similar standards and practices |
ASEAN member states aligning device classifications |
Voluntary |
These strategies aren’t mutually exclusive; they work best together.
📣 Why This Matters for U.S. Stakeholders
As the FDA continues to play a leadership role in the International Medical Device Regulators Forum (IMDRF) and other global harmonization efforts, there is growing interest in how regulatory convergence can support more efficient oversight of medical devices worldwide. While the FDA does not currently employ formal reliance pathways in the same way as some other regulatory authorities, ongoing global collaboration raises important considerations:
- Promoting global public health preparedness: When regulators share scientific approaches and align technical requirements, safe and effective technologies can reach patients in multiple regions more efficiently.
- Reducing unnecessary duplication: Convergence efforts—such as harmonized standards, common submission formats, and shared terminology—help reduce repeated evaluations across jurisdictions, supporting a more streamlined global review ecosystem.
- Enhancing efficient use of regulatory resources: As many agencies, including FDA’s CDRH, work to balance increasing workload demands, scientific collaboration and information-sharing with trusted regulatory partners can help optimize reviewer time and expertise.
- Strengthening global trust and quality: Countries such as Health Canada, the TGA, apply science-based, internationally aligned regulatory frameworks. FDA’s ongoing IMDRF participation helps shape these global principles and supports high-quality, patient-focused regulatory practices worldwide.
Through these collaborative efforts, the FDA continues to contribute to global regulatory convergence and explore approaches that maintain its high standards while supporting timely access to safe, effective, and innovative medical devices for all U.S patients.
🗣️ Final Thoughts
In the wake of the recent RIFs affecting the FDA’s device center (CDRH), regulatory reliance could become an essential tool for maintaining safety, innovation, and access—especially for moderate-risk, well-studied products
Patients deserve safe, timely access to medical innovation. In an era of global health threats, limited resources, and increasing complexity, regulatory reliance isn’t just an administrative reform—it’s a lifesaving strategy.
📚 References
- (2025, January 31). Regulatory Harmonization and Convergence. U.S. Food And Drug Administration. https://www.fda.gov/vaccines-blood-biologics/international-activities/regulatory-harmonization-and-convergence
- World Health Organization (WHO). (2021). WHO good reliance practices: Guideline for national regulatory authorities for medical products. https://www.who.int/publications/i/item/9789240020592