The European Medicines Agency (EMA) maintains a list of class waivers for medicines that are not required to submit a paediatric investigation plan (PIP) as part of a marketing authorisation application. These medicines are likely unsafe or ineffective in children, lack benefit for children or are for diseases and conditions that only affect the...

This page provides answers to specific questions from companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver. Information is also available for companies that already have an agreed PIP.

This page lists the templates and forms required by companies wishing to submit a paediatric application.

This section provides information on the European Medicines Agency's activities relating to paediatric medicines during the research and development stage. This includes guidance on paediatric investigation plans (PIPs) and other paediatric applications.

Advice for applicants for paediatric medicines, including information on how to submit their applications, what templates and forms to use, the deadlines they need to meet, and the contact points they can reach out to.

Massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) set up a joint task force to describe the big data landscape from a regulatory perspective and identify practical steps for the European medicines...