Comparative evaluation of Pediatric Drug Regulation in US, Europe and India

  • Upasana Kak M.Pharm DRA
  • Sushama Talegaonkar
  • Varsha Pradhan

Abstract

Profuse number of drugs are being labeled and tested for children for over a decade. This is mainly due to legislation and regulations passed globally which regulates and evaluates the area of pediatric drug development. (1) The challenges faced by the researchers were the right infrastructure for conducting pediatric trials on a global scale, whether or not the current regulations were working for children and adolescents. Successful propositions have been established to generate crucial information about pediatric drug safety and efficacy by Food and Drug Administration (US FDA) as well as European Medicines Agency (EMA). (2-4) These approaches have resulted in improved accountability and transparency of drug development for Pediatric use. It is high time and also the need of the hour for regulatory guidelines to be laid down by CDSCO, Central Drug Standard and Control Organization (India) so that drug development process and protocol can aim pediatric patient concerns as well. (4-8) This paper aims to review compare the Pediatric Drug Regulations of three different countries i.e. USA, Europe and India.

Keywords: Review, Guidelines/Legislations, ICH E11, Pediatric, Drug/Medicine, FDA, EMA, CDSCO, PIP, PSP, BPCA, PREA, Clinical Trials

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How to Cite
Kak, U., S. Talegaonkar, and V. Pradhan. “Comparative Evaluation of Pediatric Drug Regulation in US, Europe and India”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 3, Sept. 2021, pp. 42-46, doi:10.22270/ijdra.v9i3.485.