Toolkit for research and development of paediatric antiretroviral drugs and formulations

Overview

The toolkit identifies the challenges and outlines possible solutions for promoting and accelerating timely and high quality research and development of antiretroviral drug formulations suitable for infants, children, adolescents and pregnant and breastfeeding women.

In 2016, an estimated 2.1 million children younger than 15 years and 17.8 million women were living with HIV worldwide.

Research and development of paediatric formulations of antiretrovial drugs has traditionally lagged behind that of adult versions of the drugs, partly as a result of the shrinking market for such drugs in high-income countries. Although regulatory frameworks in both the United States and Europe have encouraged and incentivized paediatric drug development programmes in recent years, development and approval of paediatric formulations has remained a lengthy process.

Various efforts have enabled better alignment and convergence around key principles in paediatric drug development. These principles now need to be crystallized and promoted, so that higher standards in paediatric drug research can be reached.