A Comparative Review on the Regulatory Framework of Pediatric Drugs in the US and EU: Challenges and Recommendations

  • V. Sri Sowmya Sri Vasavi Institute of Pharmaceutical Sciences
  • Y.B Manjulatha
  • J. N. B Indusekhar
  • V. Bhaskar Raju


Children and adults have different pharmacokinetic and pharmacodynamic profiles, so it is necrssary to confirm the drug's effects in pediatrics. Drugs utilised in paediatric research They are frequently referred to as "therapeutic orphans" since they are challenging to develop and lack adequate data. Therefore, it becomes necessary to study the optimal dosages and formulations in various age groups of children. The significance of pediatric rules emerged from the fact that the physiological conditions of adults and children are different, and the same dosing regimen cannot be recommended for both. The child protection in research was recommended at the Belmont report (1979) first time. The necessity for written informed consent of the subject from a legally authorized representative of a child was described in the Declaration of Helsinki (1964). The scarcity of available patient populations, practical complexities of research, and minimal financial returns have hampered pharmaceutical investment in the clinical studies for children. More recently, pediatric policy in the US and Europe have instituted a system of obligations and incentives to stimulate investment in the pediatric drugs development. These initiatives, in conjunction with a more sophisticated process of drug discovery and development, resulting in significant advancements in the labelling of drugs for pediatric use. The present study reviews the regulation of pediatric drugs in the USA, EU and recent updates concerned to their regulations. It discusses the pediatric clinical study plans, Incentives, Timelines, challenges and possible recommendations. The challenges include ethical issues, clinical trial designs, type of formulation preparation, dosing, bioavailability and drug response measuring techniques.

Keywords: BPCA, PREA, Pediatric study plan, Pediatric investigation plan, Pediatric clinical trials


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How to Cite
Sowmya, V. S., Y. Manjulatha, J. N. B. Indusekhar, and V. B. Raju. “A Comparative Review on the Regulatory Framework of Pediatric Drugs in the US and EU: Challenges and Recommendations”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 4, Dec. 2023, pp. 74-86, doi:10.22270/ijdra.v11i4.635.