25/26 October 2022
The European Medicines Agency, EMA, has published the "Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation. Comments can be submitted by 31 May 2022 via the EU survey tool.
According to the agency, this new GVP guidance defines the elements of a pregnancy prevention programme (PPP) and provides for deciding when such programme is needed. The aim of a PPP is to prevent the exposure of the unborn child by ensuring that female patients are not pregnant at the start of treatment, that they do not become pregnant during the treatment, or also during a defined period after the treatment has been stopped. In addition, other risk minimisation measures can be considered appropriate to avoid adverse effects due to the use of medicines and to preserve health of both the mother and the child. A PPP is to be considered in situations where the product has the potential for
A full description of the elements of the PPP is provided in section "Risk minimisation measures constituting a PPP" of the draft guideline.
Previously, the agency already published the following GVP guidelines for comment:
Currently, the chapters on product- or population-specific considerations are available for vaccines, biological medicinal products and the paediatric population. In addition, the EMA plans to develop one more consideration chapter for the geriatric population.
More information is available on EMA´s Good Pharmacovigilance Practices website.