WHO publishes for the first time a set of dedicated regulatory guidelines for national medicines authorities in low-and middle-income countries (LMICs) to evaluate and set quality standards for oxytocin, an essential maternal health drug used for the prevention and treatment of post-partum haemorrhage, the leading cause of maternal mortality in LMIC. Today, up to 40% of oxytocin circulating in LMIC markets is substandard and these guidelines are designed to support medicines regulators in addressing the ongoing quality issues relating to oxytocin and ensuring only quality assured oxytocin products are approved and made available in the market.
A first draft of the guidelines was written by Concept Foundation’s regulatory and technical experts with funding from the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP). The guidelines were further developed and issued through a joint effort on the part of the Regulation and Prequalification, Regulation and Safety and Sexual and Reproductive Health and Research teams at the at WHO with financial support from HRP.
Concept Foundation continues to work on introduction of quality assured, affordable essential uterotonics used for the treatment and prevention of PPH through its ongoing access to maternal health medicines programme being implemented by its research and innovation and country support teams, for more information see our research and innovation and country support programme pages.