Objective: To develop target product profiles (TPPs) for new medicines for preterm birth prevention and preterm labour management that address the real-world need of women and healthcare providers, informed by views and agreement amongst globally diverse stakeholders.

Design: Mixed methods.

Setting: Global (with a focus on low- and middle-income countries, LMICs).

Sample: Global stakeholders with diverse expertise in preterm labour/birth and drug development.

Methods: Following an initial literature review, diverse stakeholders were invited to participate in an online international survey and in-depth interviews. The level of stakeholder agreement with TPPs was assessed, and findings from interviews were synthesised to inform the final TPPs.

Main outcomes measures: Level of stakeholder agreement on the minimum and preferred requirements for preterm labour/birth medicines.

Results: We performed 21 interviews. Interview participants demonstrated strong agreement on room temperature stability, no additional drug-specific clinical monitoring, and affordability in LMICs being the minimal acceptable requirements. Points of discussion were raised around the target population. Survey respondents included clinicians, researchers, funding agency staff, international public organisation staff, programme implementers, policymakers, representatives of consumer advocacy organisations and other relevant stakeholders from maternal health systems. Survey results indicated strong agreement amongst stakeholders, with only one variable in each TPP not reaching consensus (i.e. 25% disagree or strongly disagree).

Conclusions: There is strong consensus within the preterm labour/birth community on the characteristics that new medicines for preterm birth prevention and preterm labour management must achieve. These TPPs provide necessary guidance to evaluate new candidates and their potential for implementation in a range of settings.