This page provides detailed guidance for companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP.

During the 2020-23 COVID-19 public health emergency, the European Medicines Agency (EMA) provided guidance for medicine developers and pharmaceutical companies to help speed up development and approval for COVID-19 medicines and address regulatory challenges arising from the pandemic.