EMA has recently launched a public consultation on a new piece of guidance, the EU-GVP Module XVI ADD III on pregnancy prevention programmes and other pregnancy-specific risk minimisation measures.
The public consultation was launched for Addendum III of Module XVI, on pregnancy prevention programmes and other pregnancy-specific risk minimisation measures. This new guidance defines the elements of a pregnancy prevention programme and offers a framework for deciding when such a programme is needed, or if other risk minimisation measures are considered appropriate to avoid adverse pregnancy outcomes due to the use of medicines, to preserve the health of both the mother and the child. The guideline draft - EMA/608947/2021 - Draft for public consultation - may be found at the EMA website.
Instructions on making a comment can be found on the Introduction pdf accessible via the relevant GVP webpage:
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices
The consultation will be open until 31 May.
