EMA has released for public consultation a new guideline providing recommendations on how to include and/or retain pregnant and breastfeeding people in clinical trials. The goal is to ensure developers generate robust clinical data in those populations, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.
This guideline, developed jointly by global regulators and medicines developers through the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), marks a change in paradigm in the development of medicines in pregnancy and breastfeeding. It highlights that in principle, including pregnant and breastfeeding people in clinical trials should be considered for all medicines intended for people who can potentially give birth to children. It lays out the principles and conditions that should be met to ensure the safety of clinical trial participants, as well as their fetuses and babies…
