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:
- P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) 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 paediatric investigation plan
- 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 paediatric investigation plan
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.