Description
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.
Search results can be exported in Excel format.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Search for opinions and decisions on paediatric investigation plans | HTML | Open resource | |
| Download table of opinions and decisions on paediatric investigation plans (PIPs) | xlsx | Open resource |