Session II 2023 CMC Conversations in Latin America (English)

Tuesday, 19 September 2023 - Session II: Pathway to Optimizing Submission and Review of CMC Post-Approval Changes: Employing Scientific Risk-Based Principles, Reliance Pathways, Adoption of WHO Post-Approval Guidelines, and Collaborative Assessments

Session Co-Chairs: Kavita Aiyer, Seagen Inc. Susan Zavala Coloma, DIGEMID-General Directorate of Medicines, Supplies and Drugs 

Post-approval changes (PAC) to the registered information of authorized medicinal products are inevitable and often present significant regulatory burden for global submission and approval. Acknowledging the regulatory complexity within Latin America presented by diversity of CMC requirements and reporting change categories, regulatory gaps, and distinct procedures for PAC, a strategic, scientific risk-based and nimble management of data package required for submissions and subsequent review by the health agencies is foundational to speedy access of quality medicines to patients.

There is growing support for pursuing a practical approach to better leverage resources and information among regulators to reduce regulatory complexity. Ultimately, this approach would require that regulators in all participating regions adopt standardized requirements for the formats and data expectations in regulatory submissions and apply the similar standards in regulatory review, assessment, and inspection. Importantly, this would also require that sponsors submit the aligned quality dossier for the same product in all regions (i.e., same formulation, facilities, etc.). Thus, the second session of the 2023 CMC Conversations in Latin America will focus on potential solutions for the much-needed regulatory agility and effectiveness. Considerations would be given to discussing the framework of WHO PAC guidance and the benefits. This would largely encourage adaptation of this guidance by LATAM Health agencies and thus promote standardization in management of PAC for biologics. The session will also focus on opportunities and case studies for collaborative assessments pilots, reliance pathways and industry approach towards assimilation of data packages corroborating with the risk level associated with the PACs.

Post Approval Change Management Collaboration, Creativity and Commitment in a Complex Global Environment
Sarah Miksinski, Gilead Sciences, Inc.

Accelerate CMC Post Approval Changes: The Story of a Regulatory Reliance Pilot
Heraclio Rodriguez, Sanofi

Changes Post Approval of Biological Products in Perú: Regulation and Challenges Cinthia Torres Huari, DIGEMID-General Directorate of Medicines, Supplies and Drugs