Paediatric Investigation Plan
We can help you develop and align your Paediatric Investigation Plan (PIP) with the study plan.
It is not possible to file an MAA without an agreed PIP. This is a significant undertaking that should be carefully planned and executed.
Develop & Align Your Strategy
We can help you develop and align your PIP with the initial pediatric study plan required by the Food and Drug Administration.
Respond Effectively to Questions
We can draft responses to questions from the Paediatric Committee during the procedure.
Pass Compliance Checks
We can support the mandatory PIP compliance check in the lead-up to your MAA submission.
An overview of paediatric development
Suppose you’re hoping to get a medicinal therapy approved in the European Union. In that case, you are required to include the results of trials conducted in a paediatric population, as agreed in a paediatric investigation plan (PIP). Exceptions to an agreed PIP are possible if the medicinal product has been granted a deferral or a waiver. In the USA, medicine developers will complete a Pediatric Study Plan (PSP) to be reviewed by the FDA.
PIP deferrals allow you to delay developing your medicinal product in children until there is enough evidence to demonstrate its safety and efficacy in adults.
Waivers are granted in instances where the condition doesn’t occur in children or where your medicinal product would prove unsafe or ineffective in paediatric populations.
If you are required to complete a paediatric investigation plan for your medicinal product, you will also be required to complete a PIP compliance check during validation of your marketing authorisation application (MAA). Alternatively, you can request a PIP compliance check before submitting your MAA.
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.
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Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
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Subscribe to our Monthly Regulatory Intelligence Scan
Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
You can unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy here.
FAQs
Can a single PIP or PIP waiver be used for multiple marketing authorisations?
Yes. One PIP or PIP waiver can be submitted for all marketing authorisations and marketing authorisation applications for a medicinal product.
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 are the benefits of completing a paediatric investigation plan?
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.
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