The European Medicines Agency has published a policy on changes in the scope of paediatric-investigation-plan (PIP) decisions, to address problems encountered by companies making changes to their development plans.
The new policy allows the scope of a previously agreed PIP to be extended or merged if the company wishes to apply for marketing authorisation for more than one condition at the same time. It also allows companies to reduce or split a PIP if it intends to apply for fewer conditions than originally planned.
The policy also addresses related issues, such as the impact of these changes on the PIP leading to the reward and the validation of applications for a new indication that may already be covered by an existing PIP condition. It illustrates these issues with examples and practical procedural advice.
A PIP is a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of a medicine for children. Pharmaceutical companies submit proposals for PIPs to the Agency’s Paediatric Committee (PDCO), which is responsible for agreeing or refusing the plan.
Companies planning to submit a PIP or a waiver application should read the new policy, as should companies that already hold a PIP or intend to request a compliance check. They should read it together with these documents:
- Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies
- Questions and answers: Paediatric-investigation-plan guidance