Post-Approval Pregnancy Safety Study Outcomes from HMA-EMA Catalogue

A 2026 analysis of 30 post-approval non-interventional safety studies in pregnancy, extracted from the HMA-EMA Catalogue of Real-world Data Studies. The dataset, authored by Stacy Chen, summarizes the wide variation in outcomes evaluated, such as stillbirth and congenital malformations, across studies. It highlights the need for harmonized regulatory guidance to improve study comparability.

Use Cases

• Analyze the frequency of specific pregnancy outcomes like stillbirth and congenital malformations across safety studies.
• Assess the influence of study-related factors such as data collection method or regulatory agency commitment on outcome selection.
• Identify gaps in outcome reporting by comparing evaluated outcomes against FDA or EMA recommendations.
• Evaluate the statistical power of completed studies based on reported sample sizes.

Strengths

• Based on a systematic query of approximately 3100 studies in the HMA-EMA Catalogue.
• Provides specific counts for common outcomes, e.g., stillbirth (N=25 studies), congenital malformations (N=24).
• Analyzes outcomes by multiple study characteristics, including protocol year and product type.

Limitations

• The dataset is a 66.5 KB DOCX file; row count and column-level documentation are absent.
• Sample sizes from completed studies are noted to be generally low (median: 110), limiting statistical power.
• Freshness should be verified as the last update is projected for 2026-05-10.

Provenance

Source

Heads of Medicines Agency (HMA)-EMA Catalogue of Real-world Data (RWD) Studies

Collection Method

Query and extraction of registered study protocols meeting eligibility criteria.

Freshness

Last updated 2026-05-10 22:02:07