Target product profile for drugs to manage preterm labour

Overview

The World Health Organization (WHO) supports the development of essential health products aligned with identified needs and public health priorities. Recognizing that accessibility, equity, and affordability are integral components of the innovation process, WHO emphasizes their consideration at all stages rather than only after product development.

An initial target product profile (TPP) for drugs to manage preterm labour was developed and published by the Accelerating Innovation for Mothers (AIM) project led by Concept Foundation and the Burnet Institute. This external TPP has been adapted by WHO in accordance with standardized procedures.

The purpose of this TPP is to provide guidance to developers of products and funders, outlining key characteristics and desired attributes for therapeutic agents intended for pregnant women experiencing spontaneous preterm labour. This TPP delineates both the minimal and preferred characteristics of a medicine that should:

• facilitate prolongation of pregnancy, allowing for further fetal maturation in women with a high likelihood of preterm birth and administration of other therapeutics to improve fetal outcomes;
• ideally improve perinatal health outcomes;
• have an excellent safety profile during pregnancy.