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16 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com CrazyCloud - stock.adobe.com W hen a pharmaceutical manufactur- er wants to launch a product, they submit applications to dozens of in- ternational regulators for that prod- uct's review and approval. The manufacturer faces the risk that different regulators will have different expectations for the content and framework of their application. But when it comes to quality, does this have to be the case? Patients' quality expectations around the globe are consistent: safe and effective medicines free of contamination and defects. F DA P r i n c i p a l D e p u t y Com m i s s ion e r, Ja n e t Woodcock, made head lines when she foretold "a single dossier for qualit y in the cloud" and "a sin- g le reg u l ator y posit ion worldw ide" a s pa r t of a globa l approach to qua lit y (1). T hough t he world is still far from this single regulator y position on qualit y, some regulators are chipping away at the international status quo. W h i le t he Un ited States has t he la rgest si ngle pharmaceutical market in the world, over recent de- cades pharmaceutical manufacturing has globalized, and many manufact urers now strive for product launches that are global events. While a regulator may deal with one application for a new drug prod- uct, one manufacturer may deal with multiple inter- national regulators for that single product's review and approval. A public health worst-case scenario is one in which a pharmaceutical manufacturer has a promising new technology that could benefit pa- tients—and perhaps even confidence that FDA will approve it—but decides not to pursue it due to the uncertainties associated with navigating a web of globa l reg ulators. For t unately, globa l reg ulators work together to keep international expectations from becoming disjointed to the point that manu- facturers are unwilling to develop and implement innovations that might benefit patients. Convergence in the Global Regulatory Village Ashley Boam, MSBE, is the Director of the Office of Policy for Pharmaceutical Quality in FDA's Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER). Theresa Mullin, PhD serves as CDER's Associate Director for Strategic Initiatives and leads CDER's International Program. Harmonization of global regulations fosters innovation and ensures quality medicines.