Drug Safety Evaluation Methods in Pregnancy

This white paper reviews the challenges and advancements in evaluating drug safety during pregnancy, particularly for individuals managing chronic illnesses requiring ongoing pharmacological treatment. It discusses the critical need for an evidence base to balance maternal health needs with fetal safety, especially given the ethical concerns that often exclude pregnant individuals from traditional clinical trials. The paper outlines the role of regulatory guidance in shaping pregnancy exposure studies, emphasizing the importance of real-world data and innovative methodologies. It details various study designs, such as drug utilization studies and prospective pregnancy registries, which are essential for understanding medication safety and outcomes. The review highlights the advancements in data collection technologies and the necessity for standardized protocols to address ethical considerations and data privacy issues. Overall, it underscores the importance of global regulatory collaboration in enhancing the evidence base for safer drug therapy decisions for pregnant individuals and their infants.