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In this Weekly Supplement, we provide the first part of our coverage of a panel session at the 2024 CASSS WCBP Conference, which brought together regulators from five different regulatory agencies and WHO to discuss “transforming global regulatory CMC practices in an age of regulatory innovation.”
Helping set the context for the discussions that ensued at this year’s Association for Accessible Medicines (AAM) Annual Meeting, held in Tampa Florida in early February, was a review of the top FDA priorities in the generic drug regulatory arena and how the agency was seeking to address them by Center for Drug Evaluation and Research (CDER) Deputy Director Jacqueline Corrigan-Curay.
The design of appropriate in-use stability testing protocols requires strategic risk-based thinking, affirmed Health Canada (HC) Senior Biologist/Evaluator Paula Russell at a CASSS CMC Strategy Forum on in-use stability, held in late January in Washington, D.C. in conjunction with CASSS’ 2024 Well Characterized Biological Products (WCBP) Conference.

In reviewing EMA’s efforts to support manufacturing digitalization at the 2023 ISPE Pharma 4.0 and Annex 1 Conference, held in Vienna in December 2023, the agency’s Quality and Safety of Medicines Head, Evdokia Korakianiti, stressed the importance of global regulatory alignment to fully realize the quality, efficiency and product supply benefits that the IT advancement offers.

In reviewing the strategic priorities and actions of FDA’s Office of Combination Products, its leaders are pointing to an increased focus on convergence across global jurisdictions, with the goal of achieving a more consistent, efficient, risk-based regulatory approach to the combined use of drug, device, and/or biologic medical products.