European Medicines Agency releases new draft good pharmacovigilance practice guidance on pregnancy prevention programmes and other pregnancy-specific risk minimisation measures.
The European Medicines Agency (EMA) has released a draft addendum to the guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators for public consultation.
GVP Module XVI Addendum III: Pregnancy prevention programme and other pregnancy-specific risk minimisation measures
This addendum guideline defines the elements of a pregnancy prevention programme (PPP) and when such programmes or any other risk minimisation measures (RMM) are to be considered to avoid adverse pregnancy outcomes. A PPP aims to minimise the risk of exposure to a medicinal product during pregnancy by ensuring that the female patients are not pregnant at the beginning of the treatment, do not get pregnant during the course of the treatment and for a period of time post-treatment (depending on the half-life of the medicinal product). The requirement of a PPP depends on the level of scientific evidence for the teratogenic potential of a medicinal product in humans and the context of the likely use of the medicinal product. If a medicinal product is proven or strongly suspected based on animal studies to be teratogenic in humans and the magnitude and nature of the teratogenicity are significant, a PPP will be considered necessary. When the magnitude and nature of the teratogenicity do not justify a PPP, additional pregnancy-specific RMM, including SmPC/PL update, personal patient counselling by a healthcare professional (HCP), pregnancy testing before, during and after treatment and application of contraceptive measures may be considered necessary. If a medicinal product has possible/unconfirmed or unlikely teratogenicity, a PPP may not be required; however, additional RMM may still be necessary. It is worth noting that a PPP may also be required to target male patients where there is evidence that using a medicinal product by the biological father can have a teratogenic effect via semen during conception.
Comments on the draft addendum are welcomed during the public consultation period which closes on 31-May-2022. Those participating in the public consultation are asked to submit comments via the EU survey tool.
This regulatory update was produced by Dipshikha Panda, QVigilance Senior Pharmacovigilance Associate.
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