Collaboration and Reliance – From Theory to Practice

Summary Report from the DIA Latin America Annual Meeting 2025 Pre-Conference Workshop

The patients in all jurisdictions are expecting timely access to high-quality medicines and vaccines when they need them. To facilitate this public health goal, strengthening of regulatory systems in all regions is currently ongoing under the leadership of the WHO. A strong regulatory system is an essential piece for a well-functioning health ecosystem. Collaboration and sharing of information among regulatory agencies are new trends in regulatory science. 

The COVID pandemic has catalyzed increasing cooperation and collaboration amongst regulators and more frequent communication with applicants. Regulators piloted new ways of working to increase the speed of regulatory actions, achieve global alignment, and focus available resources on important public health matters. The post-pandemic years have witnessed an increase in collaboration and in the implementation and use of Reliance to support regulatory system innovation and strengthening.

Harmonization of requirements towards global standards, convergence of regulatory processes and frameworks that allow sharing of confidential information are foundational to support agency collaboration across countries and regions. In addition, the speed of technology innovation is accelerating, and the regulatory workload is increasing. To cope with this demand, regulators are implementing reliance pathways for different regulatory activities, such as initial applications, inspections, lab testing, post-approval changes, and pharmacovigilance. Regulatory reliance has become a 21st century regulatory science tool for more efficient decision making and smarter use of regulatory resources.  

Transparency and trust are necessary to establish more collaboration between regulators and contribute to global convergence. Collaboration with Industry users is key to ensure efficient, practical implementation across international markets. 

A DIA Latin America Annual Meeting 2025 Pre-Conference Workshop brought together regulators and industry stakeholders from across the region to discuss, reach a common understanding, and co-create solutions to address current bottlenecks in the practical aspects of collaboration and reliance on region-specific requirements in alignment with global standards.
The discussion highlights and action items from this Workshop have been outlined in the Outcomes Report that can be downloaded below: