Making Global Reliance A Reality For Post-Approval Changes Of Medicines And Vaccines

The article discusses the ongoing global efforts to implement reliance approaches in regulatory frameworks, particularly focusing on post-approval changes (PACs) in the pharmaceutical industry. It highlights the DIA Europe 2024 Pre-Conference Workshop where regulatory experts and industry representatives gathered to address challenges and opportunities in operationalizing reliance for PACs.

Key discussions included the variability in regulatory requirements across countries, the need for harmonization based on international standards, and the development of practical tools to facilitate reliance. Participants emphasized the importance of transparency, collaboration, and sharing best practices to streamline regulatory processes and ensure consistent product quality and availability worldwide.

The workshop concluded with actionable steps for industry and regulators to foster alignment, enhance information sharing, and advance regulatory convergence in handling PACs through reliance mechanisms.