Opinions and decisions on paediatric investigation plans

The European Medicines Agency (EMA) publishes information on opinions and decisions adopted by the EMA's Paediatric Committee (PDCO) on Paediatric Investigation Plans (PIPs) including deferrals and waivers.

A PIP is a medicine development plan aimed at ensuring the necessary data are obtained through studies in children to support the medicine's authorisation for use in children. The plan is submitted by a pharmaceutical company to the PDCO, which is responsible for agreeing or refusing the plan and for publishing an opinion with its decision. Search for:

Decision types

Decisions replaced by the latest modification of an agreed PIP

When the latest modification of an agreed PIP is published, any previous decisions remain published and can be found through EMA's medicines search.

If you cannot find the document you are looking for, you can make a formal request for access to documents using the online enquiry form.

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