Pediatric investigation plan requirements for EU, UK and US
A pediatric investigation plan sets out medicine development for children. Learn EU PIP requirements, UK differences, FDA study plans, waivers and timing.
A pediatric investigation plan sets out the development measures needed to establish how a medicine can be authorised for children. EMA and MHRA call it a paediatric investigation plan (PIP). FDA uses a separate initial pediatric study plan (iPSP).
An in-scope EU application needs the agreed PIP results and decision, or a waiver or deferral decision. Agreement to the plan does not authorise the medicine. A deferral can let some measures finish later. It does not cancel them. The filing rules are in Articles 7 and 8, and the deferral rule is in Article 20.
What a pediatric investigation plan contains
The EU defines a PIP as a research and development programme. Its purpose is to generate data that establish conditions for paediatric authorisation. The paediatric population is the group between birth and 18 years, under Article 2.
The plan specifies measures and timing to assess quality, safety and efficacy in relevant paediatric subsets. It also covers measures to adapt the formulation for those groups. Article 15 states both requirements.
A PIP is more than a list of clinical studies. It can include nonclinical work, extrapolation, modelling and simulation, formulation development and, where applicable, registries. The authority checks compliance against the agreed key elements. The Commission's application-format guideline describes these measures and application requirements.
When an EU application needs a PIP
For an in-scope new-medicine application, Article 7 requires one of the specified documentary routes. One route is results and information complying with an agreed PIP, together with its decision. The others are a product-specific waiver, a class waiver, or a deferral decision. The documentation must collectively cover all paediatric subsets. A deferral means the full programme need not always be complete at submission. See Article 7.
Article 8 extends the requirement to an application for a new indication, pharmaceutical form or route of administration for an authorised medicine that has an SPC, or a patent that qualifies for one. The documentation covers existing and new indications, forms and routes. This is narrower than saying every patented medicine or every variation needs a new PIP. Check the precise scope in Article 8.
Article 9 excludes specified pathways, including generic, hybrid, biosimilar and well-established-use applications. Certain homeopathic and herbal provisions are also excluded. Start with the intended legal basis for the application before deciding which paediatric documents it needs. The exceptions are in Article 9.
When to submit, what PDCO does and which template to use
Except in duly justified cases, submit the PIP or waiver application no later than completion of the specified human pharmacokinetic studies in adults. Do not substitute "the end of Phase I" for this legal deadline. It comes from Article 16(1).
EMA's Paediatric Committee, PDCO, assesses PIPs and requests for waivers or deferrals. PDCO gives the scientific opinion. EMA subsequently adopts the decision. Keep those stages separate when recording the status of a programme, as set out in Articles 6, 17 and 25.
For a paediatric investigation plan template, use EMA's current applications and procedures page. It contains submission instructions, IRIS material and templates. Download the current documents rather than reusing an old local form. A newer template date does not itself change the duty in the Regulation.
Waiver, deferral and PIP compliance check
A pediatric waiver and a deferral solve different problems. The EU Regulation distinguishes them as follows:
| Decision | What it changes | Grounds |
|---|---|---|
| Waiver | Removes specified paediatric development requirements for the covered scope | Likely ineffectiveness or lack of safety, an adult-only condition, or no significant therapeutic benefit over existing paediatric treatments |
| Deferral | Delays initiation or completion of some or all measures | Scientific, technical or public-health reasons, including the need for adult studies first or longer paediatric studies |
The grounds are in Articles 11 and 20. A waiver can be product-specific or a class waiver. Check which paediatric subsets or indications it covers. A partial waiver does not remove requirements outside its scope. But a deferral does not postpone the obligation to submit the plan.
Development plans can become unworkable. If agreed measures become inappropriate, Article 22 provides a route for a reasoned modification, waiver or deferral request. Do not change binding key elements unilaterally. Use the formal modification process.
For relevant authorisation applications, the competent authority verifies compliance with the agreed plan. PDCO can provide a compliance opinion. A plan decision, a compliance assessment and a marketing authorisation are separate regulatory steps under Articles 23 and 24.
EMA's October 2026 policy describes a compliance statement where the application complies with an agreed, completed PIP and the SmPC appropriately reflects the resulting findings. EMA warns that the statement does not automatically establish entitlement to paediatric rewards. See its PIP overview.
How to look up an EMA PIP decision
Start at EMA's PIP overview and follow "Opinions and decisions on paediatric investigation plans." EMA publishes these documents after removing commercially confidential information. Approved waivers and deferrals are included.
For a PIP code search or product lookup, find the relevant plan and read the decision itself. Check its scope and any subsequent modification before relying on it for submission planning. Do not treat a public summary as evidence that the medicine has marketing authorisation. The plan decision and authorisation answer different questions.
How MHRA UK PIP requirements differ
Under the framework effective from 1 January 2025, MHRA distinguishes Category 1 and Category 2 products. Category 1 products have applicable UK paediatric requirements. Category 2 products have applicable UK and EU requirements. The MHRA procedures explain this distinction.
An agreed EU PIP generally does not replace an MHRA UK-PIP decision. A UK submission is still required. MHRA considers the EU decision or PDCO opinion, but assesses UK paediatric public-health needs and can diverge. Historical adoption arrangements cover specified EMA decisions and qualifying positive PDCO opinions before 1 January 2021. Check an existing plan's status before assuming a new agreement is necessary.
In-scope UK applications need the applicable agreed or adopted UK PIP and compliance documentation, or an appropriate waiver. These requirements apply across routes, including IRP, Access and Project Orbis. MHRA expects the UK PIP submission no later than the end of healthy-subject or patient PK studies. Where PK is irrelevant, the reference point is initiation of adult Phase II proof-of-concept studies.
The UK compliance-check request is due no later than two months before the triggering regulatory submission. That deadline is in the MHRA procedures. Do not use it as the date for an EMA compliance check.
FDA uses an iPSP under PREA
The US uses a separate framework. The Pediatric Research Equity Act, PREA, establishes requirements for certain drugs and biological products. The initial pediatric study plan, iPSP, is the planning submission. Neither an EU PIP nor a UK PIP replaces it. FDA describes the framework, and the aim of pediatric labeling, on its PREA page.
The general statutory deadline is no later than 60 calendar days after the end-of-Phase 2 meeting. FDA and the applicant can agree another time, and earlier submission is permitted. This rule comes from section 355c(e)(2)(A). If a programme has no such meeting, discuss the applicable timing with FDA rather than importing an EU deadline.
FDA's final July 2020 iPSP guidance addresses contents, timing, amendments and a recommended template. Keep PREA obligations separate from voluntary BPCA exclusivity. For a programme spanning all three systems, record the EU, UK and US planning documents and deadlines separately.
RegAffairs AI provides a source-linked answer on pediatric investigation plans, including the EU, UK and US distinction.