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Paediatric investigation plan (PIP)

A PIP is a pre-requisite to filing a marketing authorization application (MAA) in the European Union (EU) and the UK.

Completing a PIP brings with it a reward, either in the form of a 6-month extension to the supplementary protection certificate (non-orphan medicinal products) or a 2-year extension to orphan exclusivity. We can help you plan and obtain whichever reward is more valuable.

How we can help 

  • develop your paediatric strategy,
  • write your PIP,
  • advise you on the use of deferrals and partial or full waivers,
  • draft the responses to questions from the Paediatric Committee (PDCO) during the procedure,
  • help you with any PIP modifications, and
  • support the mandatory PIP compliance check to pass validation in the lead-up to your MAA submission.

Often, we help companies to develop and align their PIP with the initial pediatric study plan (PSP) required by the Food and Drug Administration (FDA).

Paediatric Investigation Plan Resource

Download our free guide

Get advice on how and when to submit the PIP. This guide also includes advice on incentives for completing the PIP.

FAQs

What is a paediatric investigation plan?

A PIP is a development plan medicine developers must create and submit to the European Medicines Agency (EMA) to support a Marketing Authorisation. It includes the data you collect on your medicinal product through clinical trials conducted in children. In the USA, medicine developers will complete a PSP to be reviewed by the FDA.

Is a paediatric investigation plan mandatory?

If the medicine you are developing is not authorised in the EU, you are required to submit a PIP, which must be agreed upon by the EMA’s PDCO—unless your medicine is exempt under a class waiver. It is also possible to obtain product-specific paediatric waivers.

What are the EMA PIP timelines?

The EMA publishes the PIP submission deadlines for pediatric applications, so you can choose a timeline that aligns with all aspects of your product’s development timeline and other regulatory deliverables.

What is a PIP compliance check?

Shortly before submitting your MAA, the EMA will check your PIP to verify that you have completed all the agreed-upon measures included in your PIP.

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