This page allows you to find information on opinions and decisions adopted by the European Medicines Agency's (EMA) 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.
P: decision agreeing on a Paediatric Investigation Plan, with or without partial waiver(s) and or deferral(s)
W: decision granting a waiver in all age groups for the listed condition(s)
PM: decision on the application for modification of an agreed PIP
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
RPM: decision refers to a refusal on the application for modification of an agreed PIP
Decisions replaced by the latest modification of an agreed PIP
When the latest modification of an agreed PIP is published, any previous decisions will no longer be displayed on the decision web page accessed through the below search. However, these decisions remain published and can be found by searching the document library or using the site-wide search bar featured at the top right of every page. 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.