The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the...

HumanRegulatory and procedural guidancePharmacovigilanceResearch and development

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...

HumanEarly accessRegulatory and procedural guidanceResearch and development

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...

HumanRegulatory and procedural guidancePaediatricsResearch and development

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.

HumanRegulatory and procedural guidancePaediatricsResearch and development

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

HumanRegulatory and procedural guidancePaediatricsResearch and development

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.

HumanPaediatricsResearch and development

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.

HumanPaediatricsResearch and development

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.

HumanRegulatory and procedural guidanceResearch and development