• Publication Date: 04/01/2019
  • Author(s):
    Copley, Mark Sipitanou, Anna
  • Organization(s):
    Copley Scientific
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Instruments, Particle Characterization, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
This article reviews ways in which globalization and generics are shaping regulation and practice. A key aim is to provide insight into how the overall approach to inhaled product testing and development is evolving.

In this article, we look at recent changes in the regulatory framework, summarizing changes in United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance, the pharmacopeias, and in localized regulations from regions of growing importance for drug development and manufacture, such as Brazil and China.

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