Abstract

IMPORTANCE OF PEDIATRIC PRODUCT DEVELOPMENT AND AN OVERVIEW ON REGULATORY EXPECTATIONS, REQUIREMENTS AND PROCEDURES

M. Lakshmi Kanth* and Chung Hyun Song

ABSTRACT

In the advanced regulatory environment all competent regulatory agencies grant approval to medications for use in the patients when those have been studied for sufficient and acceptable safety and efficacy which demonstrate the benefits of usage are higher than the expected risks for which alternate treatments are available. Several medical communities have expressed increased concern that the drugs are being used widely in children despite the fact that, in most cases, information about the effects of these products in children is absent or insufficient. In response to this concern, the regulatory agencies have undertaken a number of initiatives to address the problem of inadequate pediatric testing and pediatric use information in drug, biological and medical device labeling. In order to promote the development of medications for pediatric patients national regulatory agencies have enacted different mandatory legislations and published guidance‟s explaining the procedures to follow for obtaining required approvals which lead to grant of incentives. The purpose of this article is to describe a concise overview about the regulatory initiatives made by regulatory agencies [United States Food and Drug Administration (U.S. FDA) and European Medical Agency (EMA)] to promote studies on pediatric population for the products available in market and under development products, regulatory agencies expectations, requirements and role of international collaboration in achieving the goal to generate safety and efficacy information of drugs for safe usage in pediatric population.

Keywords: Pediatric, PSP, PREA, PUMA, BPCA and FDASIA.