EMA puts the medicine data gap in pregnancy and breastfeeding under a regulatory spotlight
Pregnant and breastfeeding people use medicines every day, but the evidence base guiding those decisions remains thin. EMA’s Inside EMA podcast turns that gap into a regulatory question with direct bedside consequences: how can clinicians prescribe responsibly when most products lack safety data for pregnancy or lactation?
The episode centers on a stark imbalance in the medicines evidence system. Up to 90% of people who are pregnant or breastfeeding use medicines, yet 71% of available medicines have no data on use during pregnancy and 83% have no information on use while breastfeeding. In practice, that means clinicians often work from incomplete labels, extrapolation, or caution alone. For common conditions such as hypertension, asthma, epilepsy, depression, and infection, the absence of robust reproductive safety data can force a choice between undertreatment and uncertainty.
The biological stakes are straightforward. Drug exposure in pregnancy can affect the mother, the placenta, and the developing fetus through altered pharmacokinetics, changing protein binding, increased renal clearance, and stage-specific fetal vulnerability. During breastfeeding, transfer into milk depends on factors such as molecular size, lipophilicity, and maternal metabolism. Without direct evidence, prescribing becomes a risk-management exercise rather than a truly evidence-based decision.
Why the evidence gap persists
The podcast frames the missing data as a structural problem in drug development rather than a narrow research oversight. Pregnant and breastfeeding people are often excluded from clinical trials, which leaves safety questions unanswered long before a medicine reaches the market. Once a product is approved, real-world use expands faster than the evidence base can catch up.
This exclusion has a predictable downstream effect. Safety signals may emerge only after exposure has already become common, and clinicians are left to interpret scattered case reports, pharmacology models, and post-marketing observations. The result is not just uncertainty; it is delayed clarity for patients who need treatment now.
Corinne de Vries, EMA’s lead on medicines in pregnancy and breastfeeding, discusses how the agency wants that pattern to change across the full lifecycle of a medicine. The episode points to a broader regulatory shift: pregnancy and lactation should not be treated as afterthoughts once a product reaches the shelf. They have to be built into development, evidence generation, and post-authorisation follow-up from the beginning.
Better data, better decisions at the point of care
The practical value of stronger reproductive safety data is immediate. When a pregnant patient asks whether to continue an antidepressant, or when a breastfeeding parent needs antibiotic treatment, the answer should not hinge on guesswork. Better data would allow risk-benefit discussions to account for dose, timing, indication, and maternal disease severity instead of relying on a one-size-fits-all warning label.
The episode also makes clear that better data do not necessarily mean more rigid rules. They mean smarter rules. If pregnancy and breastfeeding are incorporated earlier into drug development, regulators can identify what should be studied prospectively, what can be informed by nonclinical and observational methods, and where post-approval surveillance should concentrate. That framework can protect fetuses and infants without automatically denying effective treatment to the parent.
The episode’s emphasis on lifecycle evidence generation fits the reality of medicines regulation. A product’s risk profile is not static; it evolves as exposure broadens across ages, comorbidities, and physiologic states. Pregnancy and lactation are among the most important of those states because they change both the biology of the patient and the stakes of the decision.
Regulatory change will depend on trial design, not rhetoric
The podcast places special attention on the need to rethink the inclusion of pregnant and breastfeeding people in clinical trials. That is the hardest operational barrier in reproductive medicine. Ethical caution has often translated into exclusion, yet exclusion itself can create harm when clinicians later have to prescribe without evidence.
Bringing these populations into research requires careful protocol design, stronger monitoring, and clear justification for what can and cannot be studied. It also demands coordination across sponsors, regulators, ethics committees, and clinical investigators. In a field where treatment decisions may affect two patients at once, the evidentiary threshold has to be high, but silence is not a safe default.
EMA’s message is regulatory in tone but highly clinical in effect. If the agency succeeds in improving the evidence base, the change will be felt not in abstract policy language but in the exam room, the maternity ward, and the community pharmacy. A patient who receives a treatment recommendation backed by pregnancy-specific or breastfeeding-specific safety information is not being asked to trust a void.
A broader lesson for medicines regulation
Episode 8 also reflects a larger theme running through the podcast series: medicines regulation depends on the quality of the underlying evidence, and evidence gaps can shape care long before a formal safety problem appears. In reproductive health, those gaps are especially consequential because the cost of uncertainty falls on patients who are already navigating physiologic change, chronic disease, or acute illness.
The podcast’s framing is direct. Better safety data are not a bureaucratic luxury. They are the condition for evidence-based prescribing when patients are pregnant or breastfeeding.
What remains unresolved is how quickly regulators, developers, and clinical researchers can make that shift routine rather than exceptional. Until then, the evidence gap will continue to shape prescribing decisions across Europe, one patient at a time.