National and subnational policies

Many national regulatory authorities, especially in resource-limited settings, lack dedicated procedures and expertise for regulating medicines used during pregnancy and the breastfeeding period. In contrast, more mature regulatory systems often develop tailored measures to support informed decision-making by pregnant and lactating women.

The WHO Listed Authority framework recognizes regulators with advanced performance and highlights examples of good regulatory practice. For underrepresented populations such as pregnant and lactating women, the use of harmonized tools enables timely and efficient safety assessment. This helps to avoid duplication of lengthy reviews and prevent delays in access to life-saving interventions. During the COVID-19 pandemic, such delays contributed to severe outcomes among pregnant and lactating women awaiting vaccination, underscoring the need for strong legal frameworks that empower regulators.

Experience with the COVID-19 vaccine introduction also showed the importance of flexibility and prioritization in regulatory decision-making. When applied by national regulatory authorities, these approaches may speed up the process of product prequalification and enable earlier access to care for pregnant women at high risk of poor outcomes, especially when paired with transparent communication on benefits and risks.

Embedding flexibility and prioritization within robust quality-management systems ensures sustainable, high-quality regulatory processes and provides structured decision pathways even when safety data for pregnancy and breastfeeding are limited.

Strong regulatory systems ultimately protect mothers and babies through timely, transparent, and inclusive decision-making.