Paediatric investigation plans: questions and answers
EMA is running a pilot for a 'stepwise PIP' agreement which would introduce a partial development programme supporting the authorisation of innovative medicines for children.
This programme would be conditional on the development of a full PIP once sufficient evidence becomes available. It would rely on predefined steps agreed with the EMA's Paediatric Committee (PDCO), such as applicants being able to hold discussions with the PDCO once they obtain more data.
Guidance on the stepwise PIP pilot is available below:
English (EN) (236.52 KB - PDF)
First published:
A stepwise PIP would apply to cases where there is a lack of crucial information needed to decide on certain parts of the paediatric investigation plan, such as whether a clinical study for a whole age group is necessary.
EMA launched this pilot in February 2023. It is due for review upon the adoption of eight initial opinions on stepwise PIPs.
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