Three reasons regulatory reliance matters now

It's about working smarter, not just harder, to ensure everyone has timely access to safe and effective medical products. By fostering global collaboration, reliance promotes agility and innovation in regulatory systems, making them better equipped to meet the health needs of populations worldwide.

1. Reliance Accelerates Access and Improves Health Outcomes

Delays in regulatory approval can cost lives, postpone diagnoses, and prolong patient suffering.  A reliance-based approach empowers regulatory authorities to leverage trusted decisions or assessments made by other established regulators, avoiding duplicative reviews and saving precious time.

The Lancet Commission on Diagnostics reports that nearly half of the world’s population lacks access to basic diagnostics, particularly in low- and middle-income countries 1. Nevertheless, reliance models, led by initiatives from the WHO and various regulatory agencies, have already improved approval times for essential diagnostics.

2. Reliance Strengthens Regulatory Systems

Contrary to some misconceptions, reliance doesn’t undermine regulatory independence. Instead, it empowers national regulators to focus resources where they are most needed—such as monitoring post-market safety and managing country-specific risks.

According to WHO data 5, approximately 75% of regulators worldwide face challenges in executing all core functions. Reliance helps close this gap by drawing on the scientific expertise of peer authorities, reducing duplication of effort, and enabling stronger, more collaborative decision-making without compromising safety or efficacy.

Additionally, digital infrastructures also play a pivotal role. Systems that enable shared access to standardized electronic dossiers, common data formats, or secure platforms are critical to scaling reliance further. Initiatives like the International Medical Device Regulators Forum (IMDRF) Table of Contents for Medical Devices and IVDs can create the foundation for a globally interconnected, future-ready regulatory system 8. 

3. Reliance Should Span the Entire Product Lifecycle

Although reliance is often discussed in the context of pre-market authorization, its benefits extend across the entire product lifecycle. Applying reliance to areas like inspections, product changes, and post-market surveillance helps build a more agile, globally aligned regulatory system.

A lifecycle approach ensures more consistent oversight, improves resource efficiency, and helps healthcare products reach patients faster—all while maintaining rigorous quality standards. This model illustrates how reliance is not just about faster approvals but about building resilient systems that adapt to changing global health needs.

Moving Forward: A Call to Action

As reliance models continue to evolve, Tammy Steuerwald, Head of Regulatory Policy, Foundational Principles & Supranational Organizations, emphasizes that “regulatory reliance must be implemented in a way that promotes trust, transparency, and accountability—tailored to each country’s regulatory system.” Building on this, three principles are emerging for effective implementation:

Key challenges remain, such as aligning different legal frameworks, bridging gaps, and developing robust digital infrastructures. That's why supporting open dialogue, shared learning, and long-term capacity building is crucial for global reliance practices.

Reliance isn't just a technical tool; it's a strategy for smarter, more collaborative healthcare regulation. And in an increasingly interconnected world, it’s a vital step toward delivering life-changing health solutions to patients everywhere.