Abstract
The pharmaceutical industry is one of the most regulated sectors globally, as it directly impacts public health and safety. Regulations are put in place to ensure the efficacy, safety, and quality of pharmaceutical products. This article provides an in-depth overview of the global regulatory landscape, focusing on key international regulatory agencies, their roles, and the challenges in maintaining regulatory compliance. Key regulatory frameworks, such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and the role of regulatory bodies like the FDA, EMA, and WHO, will be discussed. Furthermore, the article explores the harmonization efforts across countries, especially within the International Council for Harmonisation (ICH), and how these efforts influence the global pharmaceutical supply chain.
All articles published in the American Journal of Pharmaceutics are open access and licensed under the Creative Commons Attribution 4.0 International License (CC BY 4.0). This license allows users to:
-
Share — copy and redistribute the material in any medium or format
-
Adapt — remix, transform, and build upon the material for any purpose, even commercially
Under the following terms:
-
Attribution — Appropriate credit must be given, a link to the license must be provided, and any changes must be indicated.
-
Authors retain full copyright of their work.
-
The journal does not restrict reuse of content, provided proper citation of the original publication is made.