(B-264) Differential regulatory approaches to the implementation of pregnancy registries between the United States and Europe

Background: Pregnancy registries are important for monitoring maternal/child health and assessing the safety of pharmaceuticals during pregnancy, providing essential data for healthcare providers. The Food and Drug Administration (FDA) has specific guidelines and requirements for post-marketing surveillance, including pregnancy registries. This framework mandates the collection of data to monitor the safety of drugs and biologics in pregnant women. In contrast, the European Medicines Agency (EMA) does not have equivalent mandatory frameworks specifically for pregnancy registries.

Objectives: To review the FDA and EMA guidelines for post-marketing pregnancy registries and to quantify and compare pregnancy registries mandated by the FDA versus EMA

Methods: We reviewed the FDA guidance for “Postapproval Pregnancy Safety Studies Guidance for Industry” and the EMA “Annex 2. Guidance on methods for the evaluation of medicines in pregnancy and breastfeeding”. Additionally, we searched the a) FDA post-marketing requirements and commitments database, b) the FDA pregnancy exposure database, and c) the HMA-EMA catalogue for pregnancy registries from 2019 to 2024. We manually extracted data from above sources and assessed similarities and differences in pregnancy registries between the US and EU.

Results: The FDA frequently mandates pregnancy registries for certain drugs, utilizing a centralized approach to post-marketing surveillance with standardized data collection and reporting practices. In contrast, the EMA does not uniformly mandate pregnancy registries; instead, the decision is made on a case-by-case basis, often as part of the Risk Management Plan. The decentralized nature of EU healthcare systems and regulatory authorities results in variations in the implementation and management of pregnancy registries across different countries. Between 2019 and 2024, the FDA required Post Marketing Requirement or Commitment (PMR/PMC) studies for 230 drugs, with 190 ongoing pregnancy registries recorded in the FDA database. Of the 230 drugs approved, 30 (13.0%) had ongoing pregnancy registries mandated for further safety evaluation. In the HMA-EMA catalogue, 64 (35.6%) of the 180 pregnancy registries were implemented or ongoing in at least one EU member state between 2019 and 2024, of which 9 (14.1%) were imposed as condition of marketing authorisation. Detailed assessments of drugs approved between 2019 and 2024 and pregnancy registries between the US and the EU will be described.

Conclusions: While the FDA commonly mandates pregnancy registries in the US, the EMA adopts a more flexible, case-by-case approach. This difference is influenced by variations in regulatory frameworks, healthcare systems, and data collection methods between the US and Europe.