Page 26 - ITPS-7-4

INNOSC Theranostics

and Pharmacological Sciences

REVIEW ARTICLE
Pediatric drug regulations: A global perspective

and the imperative for implementation in India

Mangesh Tatar † , Swati Jadhav* , Lisha Wadhava † ,
Aman Upaganlawar*, and Chandrashekhar Upasani
Department of Pharmacology, Faculty of Pharmacy, SNJB’s Shriman Suresh Dada Jain College of
Pharmacy, Nashik, Maharashtra, India

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,
† These authors contributed equally challenges, and advancements shaping this field. Commencing with a historical
to this work. backdrop, the review outlines the evolution of regulatory frameworks across major
*Corresponding authors: regions, including the United States (US), Europe, Japan, and China, while underscoring
Swati Jadhav the imperative for the implementation of pediatric drug regulations in India. These
(jadhav.sscop@snjb.org)
Aman Upaganlawar regulations mandate age-appropriate dosing, rigorous clinical trials, and thorough
(upaganlawar.abcop@snjb.org) 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
Citation: Tatar M, Jadhav S,
Wadhava L, Upaganlawar the US Food and Drug Administration oversee these regulations, ensuring pediatric
A, Upasani C. Pediatric drug drugs meet safety standards before approval. In addition, regulations often include
regulations: A global perspective provisions for informed consent and parental involvement in treatment decisions,
and the imperative for
implementation in India. INNOSC aiming to protect children from adverse effects while providing effective therapeutic
Theranostics and Pharmacological options tailored to their developmental needs. In summary, this review emphasizes
Sciences. 2024;7(4):3831. the importance of global cooperation and harmonized regulations in advancing
doi: 10.36922/itps.3831
pediatric drug research. It highlights recent progress while acknowledging ongoing
Received: June 4, 2024 challenges and opportunities in this critical area.
Accepted: August 28, 2024
Published Online: November 4, Keywords: Pediatric drug regulations; Drug development guideline; Clinical trials; Best
2024 Pharmaceuticals for Children Act; Pediatric Research Equity Act; Pediatric use marketing
Copyright: © 2024 This authorization; Food and Drug Administration; European Medicines Agency
is an Open-Access article
distributed under the terms
of the Creative Commons
AttributionNoncommercial License,
permitting all non-commercial use, 1. Introduction
distribution, and reproduction in any
medium, provided the original work Pediatrics focuses on the physical, social, and mental well-being of individuals from
is properly cited. birth through adolescence. The pediatric population is divided into preterm newborn
1
Publisher’s Note: AccScience infants (from childbirth to 27 days after the predicted date) and post-term newborns
Publishing remains neutral with (0 – 27 days old), infants and toddlers (28 days – 23 months old), children (2 – 11 years
regard to jurisdictional claims in
published maps and institutional old), and adolescents (12 – 16 or 18 years old, depending on the region) according to
affiliations the International Council for Harmonization (ICH) topic E11 (CPMP/ICH/2711/99)

Volume 7 Issue 4 (2024) 1 doi: 10.36922/itps.3831