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REVIEW

Pediatric drug regulations: A global perspective and the imperative for implementation in India

Mangesh Tatar1† ,  Swati Jadhav1* ,  Lisha Wadhava1† ,  Aman Upaganlawar1* ,  Chandrashekhar Upasani1
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1 Department of Pharmacology, Faculty of Pharmacy, SNJB’s Shriman Suresh Dada Jain College of Pharmacy, Nashik, Maharashtra, India
INNOSC Theranostics and Pharmacological Sciences 2024, 7(4), 3831 https://doi.org/10.36922/itps.3831
Submitted: 4 June 2024 | Accepted: 28 August 2024 | Published: 4 November 2024
© 2024 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Abstract

The pediatric population differs from adults in various ways, including physiological factors, pharmacokinetics, pharmacodynamics, and dosage administration. However, many medications prescribed for children are formulated for adults, necessitating dose adjustments throughout childhood. This underscores the need for pediatric drug formulations and regulations worldwide. This review delves into the intricate landscape of international pediatric drug regulations to elucidate key initiatives, challenges, and advancements shaping this field. Commencing with a historical backdrop, the review outlines the evolution of regulatory frameworks across major regions, including the United States (US), Europe, Japan, and China, while underscoring the imperative for the implementation of pediatric drug regulations in India. These regulations mandate age-appropriate dosing, rigorous clinical trials, and thorough labeling to prevent misuse. They require pediatric-specific studies to understand drug effects and dosages and enforce guidelines for off-label use. Agencies such as the US Food and Drug Administration oversee these regulations, ensuring pediatric drugs meet safety standards before approval. In addition, regulations often include provisions for informed consent and parental involvement in treatment decisions, aiming to protect children from adverse effects while providing effective therapeutic options tailored to their developmental needs. In summary, this review emphasizes the importance of global cooperation and harmonized regulations in advancing pediatric drug research. It highlights recent progress while acknowledging ongoing challenges and opportunities in this critical area.

Keywords
Pediatric drug regulations
Drug development guideline
Clinical trials
Best Pharmaceuticals for Children Act
Pediatric Research Equity Act
Pediatric use marketing authorization
Food and Drug Administration
European Medicines Agency
Funding
None.
Conflict of interest
The authors declare they have no competing interests.
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INNOSC Theranostics and Pharmacological Sciences, Electronic ISSN: 2705-0823 Print ISSN: 2705-0734, Published by AccScience Publishing
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