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.

The sponsor of a designated orphan medicine can request removal of its orphan designation from the European Commission's Community register of orphan medicinal products at any time.

The European Medicines Agency's scientific guidelines on the biological substances other than immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.

PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach...

The European Medicine Agency's (EMA) scientific guidelines on real-world evidence aim support the use of real-world data in regulatory decision-making.