World Journal of
Pharmaceutical and Life Sciences

"COMPARATIVE ANALYSIS AND ENHANCEMENT STRATEGIES FOR PEDIATRIC INVESTIGATION PLANS IN THE USA, EU, AND INDIA: ADDRESSING REGULATORY FRAMEWORK CHALLENGES AND RECOMMENDATIONS"

*Dr. Shailaja Pashikanti, Chegudi Lidiya Kusuma Latha, Manthena Sanjay Samanth, Mantri Shiva Kumar

ABSTRACT

The physiological differences between children and adults present special problems for pediatric medication development, requiring customized methods for formulation and dosage optimization. The goal of recent regulatory actions in the US and Europe is to encourage pharmaceutical companies to fund pediatric research. since it leads to significant advancements in the creation of medications for use in children. This study sheds light on the disparities and shortcomings in the treatment of pediatric medical requirements by offering a thorough comparative examination of pediatric drug legislation in the USA, EU, and India. The European Pediatric Regulation (EC) No 1901/2006 places a strong emphasis on enhancing children's protection in research settings, even if the FDA in the United States has set up strong pediatric regulations and incentives to support pediatric research. India is contrasted with these developed nations as a developing nation.

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