Studies in Support of Special Populations

7. Studies in Pregnant Women

In general, pregnant women should be excluded from clinical trials where the medicine is not intended for use in pregnancy. If a woman becomes pregnant whilst receiving the medicine, treatment should generally be stopped (if this can be done safely).

For clinical trials that include pregnant women because the medicine is intended for use during pregnancy, it is very important to follow-up of the pregnancy, foetus, and child. In addition, safety data from previous human exposure should be evaluated.

    • Toxicity studies must be included as well before pregnant women are included in clinical trials. The studies include female reproduction toxicity studies - studies that look at the risk of damage to reproductive organs.
    • The standard range of genotoxicity tests - studies that look at the effect on genes.