FDA signals a new era for pregnancy registries: What biopharma needs to know

The U.S. Food and Drug Administration’s (FDA) May 2026 Optimizing Pregnancy Registries workshop marked a meaningful step in the evolution of pregnancy safety evidence generation. The overarching message was not that pregnancy registries are becoming less important, but that they must evolve.

Medication use during pregnancy is common, but timely human safety data are still limited, leaving pregnant patients and their providers without the evidence they need to make informed treatment decisions. The FDA convened this workshop to bring together regulators, industry, academia, healthcare providers, patients and other stakeholders to improve how pregnancy studies are designed, implemented and conducted to generate more timely, clinically meaningful evidence on miscarriage, birth defects, and neurodevelopment outcomes. Against that backdrop, the workshop explored integrated strategies and collaborative approaches to strengthen pregnancy safety evidence generation.

Traditional, product-specific pregnancy registries remain foundational for prospective safety data. However, workshop discussions highlighted they are often too slow, too fragmented and difficult to recruit to meet today’s regulatory and clinical needs. Instead, administration stakeholders are placing greater emphasis on integrated evidence generation that combines registries with real-world data (RWD), electronic health records (EHRs), claims data, patient-reported outcomes, and, where feasible, collaborative approaches that connect data and evidence across registries and sponsors.

The challenge isn’t just data — it’s time

More than 80% of women report taking at least one medication during pregnancy, yet meaningful human safety data often take 10–18 years to emerge. During that time, clinicians must make treatment decisions with limited evidence, while patients seek answers about miscarriage, birth defects and their child’s long-term health.

Recruitment remains a major challenge. Low enrollment consistently delays study completion and labeling updates across therapeutic areas, prompting broad discussion about ways for pregnancy studies to better reach eligible patients.

Stakeholders agree on the need for proactive evidence

The workshop revealed several common themes across stakeholder groups, even though their challenges differ.

• Healthcare providers emphasized that they need practical, clinically relevant evidence that balances maternal disease control against fetal risk.
• Patients increasingly want information that extends beyond birth outcomes to include infant development, infections, hospitalizations and longer-term child health.
• The industry continues to struggle with a fundamental uncertainty: before launch, sponsors rarely know how many pregnant patients will ultimately use a new therapy, making traditional registry planning difficult.

The FDA is expanding its expectations

One of the workshop’s most important themes was the FDA’s evolving regulatory framework.

The agency’s 2026 pregnancy safety guidance broadens expectations beyond traditional registries by emphasizing integrated, lifecycle evidence generation. The guidance supports a more integrated approach to pregnancy safety evidence generation, including consideration of pregnancy registries, database studies and other observational approaches based on the research question and available data.

Key considerations highlighted in the workshop and guidance include:

• Conducting feasibility assessments before launching registries
• Implementing greater use of integrated RWD/real-world evidence (RWE) and non-interventional methodologies
• Applying more rigorous approaches to comparator selection and study methodology
• Expanding postpartum and lactation outcomes
• Developing stronger methodological standards for electronic healthcare data analyses

These themes closely align with the FDA’s ongoing work under the Prescription Drug User Fee Act (PDUFA VII), which is evaluating how registries, claims data, and EHR studies can be used to support regulatory decision-making.

Exploring collaborative approaches

Workshop participants also explored whether greater coordination across existing registries, data sources and sponsors could improve efficiency and reduce duplication.

While these approaches offer potential advantages, the discussion also underscored significant practical barriers that could prevent collaborative models from being implemented and sustained, including funding, sponsor willingness to share data and infrastructure, governance and long-term sustainability.

Models discussed included:

• Coordinated Registry Networks (CRNs) linking registries, EHRs, claims and patient-generated data
• Multi-product, multi-sponsor registries, such as the Antiretroviral Pregnancy Registry
• Federated national registry concepts built around common data elements and shared infrastructure

The idea of a single national pregnancy registry generated considerable discussion. Participants explored the potential of a federated infrastructure that builds on current investments while simplifying enrollment, standardizing data collection, and accelerating evidence generation, rather than replacing existing registries. However, discussion made clear that translating such concepts into sustainable models would require addressing not only privacy, governance and participant trust, but also fundamental questions around funding, sponsor participation, data sharing and long-term ownership.

Looking ahead

The workshop also placed the FDA’s efforts within a broader international movement. Emerging frameworks, including the draft International Council for Harmonisation (ICH) E21 guideline, reflect a growing emphasis on generating pregnancy evidence earlier in clinical development, while evolving regulatory approaches in Europe and elsewhere seek to strengthen post-marketing evidence through complementary study designs and real-world data.

For biopharma companies, the direction is increasingly clear: pregnancy registries remain essential to integrated, lifecycle evidence-generation strategies that combine prospective registries with high-quality RWE. Collaborative models may ultimately play a role in that evolution, but their viability will depend on overcoming significant operational, financial and data-sharing barriers.

Key takeaways for sponsors

• Pregnancy registries remain foundational but are no longer expected to operate in isolation.
• Recruitment and participant awareness (not study design alone) remain major barriers to timely evidence generation.
• FDA guidance increasingly supports integrated evidence generation strategies that combine registries, claims, EHRs, and complementary observational studies.
• Collaborative approaches, including CRNs and multi-sponsor registries, may offer a path toward more efficient and sustainable evidence generation, but significant funding, governance and data-sharing challenges remain.
• Investments in patient-centered recruitment, interoperable data infrastructure, and robust RWE capabilities are likely to become important competitive differentiators.

Related resources

• Watch our pregnancy safety studies webinar for insights on designing and conducting more effective pregnancy safety studies.
• Explore our pregnancy and lactation safety studies guide for expert strategies to build more efficient, patient-centric studies.