Before a new drug can be evaluated in children, a paediatric investigation plan (PIP, in the European Union) or a paediatric study plan (PSP, in the USA) must be approved by regulatory authorities.
A PIP/PSP is a development plan that outlines the steps that will be taken to generate data to support approval of a drug or treatment in children.
Submitting a PIP to the EMA
The European Medicines Agency (EMA) requires that PIPs be submitted early in product development, at the latest at the completion of human pharmacokinetic studies.
The early deadline is to ensure that paediatric studies can be completed before submission of a marketing authorization application and to allow time for discussions between a trial sponsor and the EMA Paediatric Committee (PDCO).
A PIP waiver exempts a sponsor from developing a PIP. A waiver may be issued if an infection occurs only in adults, the treatment is unlikely to work or be safe in children, or there is evidence of no significant therapeutic benefit in children or treatment would not be feasible to deliver.
Full details can be found in the EMA’s Paediatric Regulation.