Early and collaborative engagement with regulatory agencies is essential to avoid delays in regulatory approval and trial implementation. Although some jurisdictions have regulations that restrict the participation of pregnant and breastfeeding women in research, decisions to exclude these populations are often driven by investigators’ concerns about prolonged approval timelines and associated costs. Regulatory considerations related to the inclusion of pregnant and breastfeeding women are generally consistent across disease areas; therefore, these issues are discussed in detail in the knowledge portal. 

In the preclinical section, a case study of ASTERoiD / TBTC Study 37 is presented as an example of a TB‑specific trial that successfully obtained an Investigational New Drug (IND) authorization from the FDA to include pregnant women, despite concerning preclinical data for rifapentine. The other case studies in this toolkit (​​see TB CHAMP and BEAT TB case studies) demonstrate additional examples of studies that included pregnant and lactating women and were approved by the South African Health Products Regulatory Authority.