The pandemic has brought about an expectation of increased speed to deliver new medicines to patients, while the boundaries of science are being extended to deliver life-changing drugs to treat, prevent, modify, and even cure diseases. For example, ATMPS (Advanced Therapy Medicinal Products), MIDD (Model-Informed Drug Development) and advanced manufacturing technologies are being utilized for the next generation of medicines. However, more can be achieved through continual improvement. Variations on regulatory assessments for the same drug create challenges to maintain the dossier throughout the lifecycle of the product and to implement post-approval changes that help prevent potential drug shortages. A collaborative effort to understand the degree of divergence and impact is an important step toward improved global harmonization of control strategies. The ISPE Global Regulatory Town Hall will provide a forum to initiate a dialog between industry and regulators with the goal to formulate sustainable solutions.
Director, Center for Biologics Evaluation and Research (CBER),
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