Global Regulatory Landscape
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Continuous manufacturing (CM) of pharmaceuticals is a rapidly growing approach in the production of active pharmaceutical ingredients and finished products. The European Medicines Agency, the US Food and Drug Administration, and the Pharmaceuticals and Medical Devices Agency have independently stated their support for the introduction of CM and provided opportunities for early dialog between industries and regulatory agencies. This paper describes the current regulatory landscape and the regulatory harmonization.
KEY WORDScontinuous manufacturing PMDA regulatory harmonization regulatory convergence
I thank Sau L. Lee (US FDA) and Dolores Hernan (EMA) for sharing information about ETT and PAT team.
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