Drug Safety in Pregnancy: Review of Study Approaches Requested by Regulatory Agencies

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Traditionally, post-authorization safety studies (PASSs) for a drug’s use in pregnancy have consisted of pregnancy exposure registries. Pregnancy-related PASSs are increasingly relying on real-world data to assess potential safety issues that could not be assessed in pre-approval clinical trials. 

Different study approaches have different strengths and limitations. Larger, well-designed studies that have a long enrollment period can be valuable. On the other hand, studies with low enrollment, no protocol report, or substantial loss to follow-up can be uninformative.

Research published in the July 2019 edition of Current Epidemiology Reports examined post-authorization pregnancy safety studies requested by the US FDA and EMA to understand which approaches are typically requested and how the approaches have changed over time. Our findings indicate that in the last couple of years, the FDA has commonly asked for two types of studies–a pregnancy exposure registry and a database study–to assess pregnancy and fetal outcomes for drugs granted marketing approval. The EMA appears to be shifting its preference toward studies using preexisting electronic health care data sources from multiple countries. 

To see the full research publication, click here.

 

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