Regulatory science for paediatric medicines in low- and middle-income countries

Abstract

Introduced into pharmaceutical parlance by Margaret Hamburg, US FDA Commissioner, the term ‘regulatory science’ covers ‘the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality’. We looked at what is new in this area concerning paediatric medicines, and in particular how these advances could be useful for children in Low- and Middle-Income Countries (LMIC).