Regulatory reliance is increasingly being used by National Regulatory Authorities (NRAs) of all maturities with different regulatory systems.

This concept is actively promoted by organizations such as World Health Organization (WHO), the Pan American Health Organization (PAHO), and the European Medicines Agency as a mechanism for NRAs to better manage resource capacity issues while simultaneously strengthening regulatory systems.

The IFPMA recognizes that regulatory reliance offers opportunities for all stakeholders impacted by regulatory systems:

•  Patients and healthcare providers: Timely access to safe, effective and quality medical products.
• National Regulatory Authorities: Efficient utilization of resources by avoiding duplication of work and providing opportunities to strengthen the regulatory system, while maintaining sovereignty over decision-making.
• Industry: Streamlined management of regulatory submissions and global supply systems as well as predictable, timely approvals.

In this paper, IFPMA outlines key elements for NRAs to consider when establishing and implementing effective regulatory reliance mechanisms.