New GVP Guideline for Populations of Pregnant or Breastfeeding Women

The new document provides guidance to marketing authorisation holders (or applicants) and competent authorities on conducting pharmacovigilance processes for the populations of pregnant or breastfeeding women (or individuals).

Background

In addition to the benefit-risk ratio for female patients, beneficial effects and particularly risks for the embryo, fetus, neonate, infant or child must be considered. When it comes to breastfeeding, the benefits of breastfeeding itself must be weighed against the risks posed by the medicinal product to the neonate, infant or child exposed to it through breast milk.

Additionally, the medicinal product's effects on breast milk production and breastfeeding itself should be considered. Safety data obtained for these evaluations in the pre-authorisation phase is generally limited. In the post-authorisation phase, it is important to collect data to better characterise safety, even where no safety concerns regarding pregnancy or breastfeeding have arisen in the pre-authorisation phase. The overall aim, based on the assessment of these data, is to provide patients and healthcare professionals with information to support therapeutic decision-making about the use of medicinal products during pregnancy or breastfeeding.

Amongst others, the following documents should be consulted in addition to the new GVP Guideline:

• EMA Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling;
• ICH-S5(R3) Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals.

For more information please see Eudralex Volume 9 Product- or Population-Specific Considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk.