Global Medicines Program

March 4, 2024

Landscape analysis of pregnancy exposure registries in low- and middle-income countries


Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.

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Supported by the BMGF, this work was a collaboration between PATH, WHO and the University of Washington Global Medicines Program.