Tuesday, 6 June 2023 – Session I: Why optimize the submission and review of CMC post-approval changes? Global trends and challenges for Latin America

Session Co-Chairs: Cammilla Horta Gomes, Produtos Roche Químicos e Farmacêuticos S.A., Karina Cuadra, Ministerio de Salud Publica de Uruguay (Invited)

Post-approval changes (PAC) to the registered information of authorized medicinal products are routinely introduced worldwide, and their review represents a significant and increasing workload for regulators. Moreover, handling many different types of dossiers for the same product and managing change implementation worldwide is burdensome for industry. In Latin America, the diversity of CMC requirements and reporting change categories, regulatory gaps, and distinct procedures for PAC continue to represent a challenge, with potential impact on the availability of medicinal products in the region.

The first edition of the 2023 CMC Conversations in Latin America will be a virtual interactive session, gathering regulators and industry - from the region and beyond - to explore solutions in optimizing the submission, review, and implementation process of CMC variations, focusing on convergence with international standards and adoption of best practices.

Global Trends in Lifecycle Management

Hugo Hamel, Health Canada

Manufacturing processes are often altered after regulatory approval and medicines can undergo changes during their product lifecycle. Changes are essential for the continual improvement of the manufacturing process and for maintaining state-of-the-art controls of medicinal products, and often need to be implemented after the product has been approved. With the approval of new products every year, the number of post-approval changes requiring regulatory approval keep increasing and can delay

access to important drugs to patients. This presentation will highlight the importance of having a regulatory framework in place which use a risk-based approach for lifecycle management. It will also highlight different tools that are available to help manage the post-approval changes.

Online Optimized Assessment Project for CMC Variations
Carolina Blades, ANVISA

Reliance for Post-Approval Changes: An Industry Perspective
Maria Antonieta Román, Latin American Federation of the Pharmaceutical Industry - FIFARMA

Karina Cuadra

Ministerio de Salud Publica de Uruguay

Appearances