Strong regulatory frameworks provide a predictable and efficient pathway for scientific advancements to translate into real-world impact, ultimately leading to better health outcomes for patients worldwide.

National Regulatory Authorities (NRAs) play a vital role in ensuring that patients receive safe and effective medical products. Their collaboration and constant dialogue with pharmaceutical companies at every stage — from R&D to clinical trials and post-approval monitoring — are key to success. Additionally, NRAs rely on each other to maintain high regulatory standards, fostering a more efficient and globally connected regulatory environment.

Over the past months, we have worked closely with members of the IFPMA regulatory science committee to shape our engagement at DIA Europe 2025 – a key platform for sharing industry experience and engaging with regulatory authorities around the world.

Two central themes have emerged: regulatory reliance and how regulatory systems can accelerate access to breakthrough medical innovations, while ensuring supply chain resilience and continuity.

The role of regulatory reliance

As pharmaceutical R&D becomes increasingly global, regulatory reliance offers a powerful tool for improving regulatory efficiency, particularly in regions where resources are limited. According to the WHO, regulatory reliance is a hallmark of a mature regulatory system, signifying efficiency, transparency, and trust in regulatory decision-making.

By leveraging existing regulatory assessments, reliance helps avoid duplicative reviews, accelerates approvals, and optimizes resources, ultimately speeding up regulatory processes through predictable timelines that accelerate patient access to innovative medical products around the world.

Regulatory reliance can be applied across the entire product lifecycle: inspections, post-approval changes, clinical trials, quality control.

However, for reliance to be effectively implemented, certain challenges related to regulatory capacity-building, trust in external evaluations, and alignment of regulatory processes, need to be addressed. Strengthening regulatory reliance frameworks will require continuous collaboration between regulatory authorities, industry stakeholders, and global health organizations. This is why DIA Europe provides such a powerful platform for engagement.

Convergence and collaboration: Building mutual trust

Mutual trust between all parties is the foundation of regulatory reliance, and transparency is a key principle for good regulatory practice. To facilitate reliance activities, IFPMA has developed a template that provides a transparent overview of differences between the documentation submitted for marketing authorization or post-approval changes in the relying and the reference NRA. This template is being tested, with the aim to help streamline reliance-based assessments and foster greater trust between industry and NRAs.

Beyond templates, accurate and comprehensive data is crucial for making informed decisions about convergence and reliance. IFPMA worked with Clarivate to gather feedback from experts  and publicly available sources on how different countries regulate post-approval changes (PACs) in biotherapeutic products. The findings reveal significant variations in regulatory approaches, emphasizing the need for greater convergence with WHO standards.

Discussions around regulatory reliance, convergence, and trust are critical to shaping a more agile and patient-centered regulatory landscape. Through collaboration with and between regulatory bodies, we can reduce barriers to access and streamline approval processes.

Author

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  Julie O’Brien Senior Director, Europe and International Regulatory Policy Head, Pfizer