Use of regulatory reliance for greater convergence in the Americas

computer health regulation

Washington DC, 17 November 2022 (PAHO) - The Pan American Health Organization (PAHO) held the webinar “Enabling the use of Regulatory Reliance in the Americas”, on 17 November 2022, seeking to promote the exchange of information and experiences towards greater regulatory convergence in the Region. 

The activity was organized by the Pan American Network for Drug Regulatory Harmonization (PANDRH), and aimed to identify opportunities, discuss major remaining obstacles, and recommend a path forward to expand the use of reliance. 

Reliance is a critical efficiency for regulatory systems that can be used across a variety of regulatory functions in pre- and post-market stages. It helps reduce workload so that resources can be prioritized elsewhere in all regulatory systems, regardless of their size and/or existing resources. 
In the first session of the activity, the speakers discussed the context and value of regulatory reliance in promoting a more efficient approach to the regulation of medical products.

“The challenges we faced during the pandemic have shown us that reliance mechanisms were key for us to cope with the emergency situation, and we are at a good juncture now to reflect on how we can adapt these mechanisms beyond the pandemic in a more systematic, transparent and predictable way,” said Maria Baca Estrada, Manager, Clinical Evaluation Division: COVID, Center for Vaccines, Clinical Trials and Biostatistics, Health Canada. 

Likewise, presenters reviewed lessons learned from National Regulatory Authorities of Regional Reference (NRAr) and other organizations on inter-institutional collaboration towards the adoption and implementation of reliance mechanisms. 

“Several opportunities exist for the use of regulatory reliance, and its practice can take varying forms and degrees. Each regulatory authority needs to determine its own specific strategy and appropriate approaches based on a risk-benefit assessment,” said Maria Luz Pombo, Advisor, Vaccines and Biotechnological Products, Medicines and Health Technologies Unit, PAHO/WHO.

The second session focused on how to increase use of reliance. Panelists discussed on challenges and opportunities to enable the effective use of reliance throughout the product life cycle, and the role that regulated parties and other stakeholders in the system can play in achieving an efficient regulatory environment.

“Regulation by reliance pathways is now a 21st century best regulatory practice, and it has been incorporated into a WHO guideline on good reliance practice,” said Murray Lumpkin, Deputy Director, Regulatory Affairs, Bill & Melinda Gates Foundation. When it comes to enabling the use of reliance, Lumpkin highlighted that “we all know that is not just the regulatory authorities, it is the industry, it is other stakeholders in the regulatory ecosystem who have very important roles to play.”

Close 500 people participated, from 46 countries, including PANDRH members, and related actors from the public and private sectors, as well as from non-for-profit Organizations involved in advancing regulatory efficiencies through convergence, harmonization, and reliance.