ReferralHuman
MedicineHumanAuthorised

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

The European Medicines Agency grants deferrals for some medicines. These allow an applicant to delay development of the medicine in children until there is, for instance, enough information to demonstrate its effectiveness and safety in adults.

HumanRegulatory and procedural guidancePaediatrics

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP, unless the...

HumanPaediatrics

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

The European Medicines Agency has a number of important tasks and responsibilities relating to the development of paediatric medicines. These responsibilities, granted through the European Union (EU) Paediatric Regulation, enable the Agency to stimulate research into the uses of medicines in children and to lead to their authorisation in all age...

HumanPaediatrics

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