A significant barrier to improving global maternal and perinatal health is under-investment in pharmaceutical research and development (R&D) of medicines for pregnancy-specific conditions. Target product profiles (TPPs) are a well-recognised strategy to promote development of innovative medical products, such as devices, diagnostic tests and therapeutics.
The World Health Organization (WHO) defines a TPP as a document that describes the minimum and preferred (or optimal) characteristics of a target product, aimed at a particular disease or diseases. They specify the key characteristics that the intervention must address, such as (but not limited to) clinical indication, target population, desired efficacy, safety, formulation/presentation and stability and storage. TPPs are an important resource for multiple stakeholders in the R&D pathway, including funders, researchers, product developers, manufacturers and regulators.
The two TPPs presented here have been formulated to meet the needs for novel drugs to prevent and treat for pre-eclampsia. Pre-eclampsia is the most common hypertensive disorder of pregnancy, affecting an estimated 4.6 percent of pregnant women globally, and is a leading cause of maternal mortality. The only cure for pre-eclampsia is birth of the baby and delivery of the placenta, and there is lack of effective medicines for preventing and treating pre-eclampsia.
Your views on medicines for pre-eclampsia
This page contains draft documents of two TPPs for:
- the prevention, and
- the treatment of pre-eclampsia for public consultation.
If you wish to submit a response, please email [email protected]
For your information, all the comments you provide will be treated as non-identifiable, which means that we will not attribute these comments to you by name, nor will anything that could identify you be released outside of our study team.