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AAPS PharmSciTech

, 20:2 | Cite as

Global Regulatory Landscape

  • Yoshihiro MatsudaEmail author
Mini-Review Theme: Continuous Manufacturing of Pharmaceutical Products
  • 111 Downloads
Part of the following topical collections:
  1. Theme: Continuous Manufacturing of Pharmaceutical Products

Abstract

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 WORDS

continuous manufacturing PMDA regulatory harmonization regulatory convergence 

Notes

Acknowledgements

I thank Sau L. Lee (US FDA) and Dolores Hernan (EMA) for sharing information about ETT and PAT team.

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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  1. 1.Pharmaceuticals and Medical Devices Agency (PMDA)TokyoJapan

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