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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.

The European Medicines Agency (EMA) publishes opinions on the qualification of innovative development methods and letters of support for novel methodologies that have been shown to be promising in the context of research and development into pharmaceuticals.

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...

Following the positive evaluation of a plasma master file (PMF) under the PMF certification scheme, the European Medicines Agency (EMA) issues a certificate of compliance with European legislation which is valid throughout the European Union. EMA publishes the list of all the issued PMF certificates.