'Femi Fajimi

Understanding the Paediatric Investigation Plan (PIP): How It Differs from a Clinical Trial Protocol 

By Femi Fajimi | 02 June 2025 

Introduction 

When I first heard the term Paediatric Investigation Plan (PIP), I assumed it was just a clinical trial protocol for children. But I soon realised it’s a much broader regulatory tool, one that maps out how medicines will be studied in children throughout development. 

In regulatory medical writing, understanding the purpose of each document matters. Unlike protocols, which detail the conduct of a single study, a PIP outlines a long-term paediatric strategy. It ensures that children are considered early, not after adult data is in place. 

What Is a PIP? 

A Paediatric Investigation Plan (PIP) is a regulatory document required by the European Medicines Agency (EMA) under Regulation (EC) No 1901/2006. It specifies how a medicinal product will be investigated for use in children (birth to <18 years) and must be agreed with the EMA’s Paediatric Committee (PDCO) before submitting a marketing authorisation application (MAA) in the EU. 

Key Components: 

• Rationale for paediatric development 

• Study designs (including non-clinical, pharmacokinetic, efficacy, and safety studies) 

• Age subgroup justifications (e.g. neonates, infants, adolescents) 

• Waivers or deferrals, where appropriate 

• Timelines for proposed studies 

• Paediatric formulations to be developed 

How a PIP Differs from a Clinical Trial Protocol 

Aspect	PIP	Clinical Trial Protocol
Purpose	Strategic roadmap for paediatric development	Operational plan for one specific study
Scope	Covers multiple studies, age groups, and phases	Focuses on one trial
Regulatory Role	Required for EU MAA submission	Required for trial approval (e.g. CTA, ethics)
Includes Adult Data?	Yes, for justification (e.g. waivers)	Not typically
Reviewed By	EMA’s Paediatric Committee (PDCO)	National Ethics Committees / Competent Authorities
Includes Waivers/Deferrals?	Yes	No
Focus	Justification, long-term planning, population needs	Trial design, endpoints, procedures

What Medical Writers Should Know 

As regulatory writers, we may be involved in authoring, reviewing, or summarising aspects of the PIP. Key contributions include: 

• Writing or editing justifications for waivers or deferrals 

• Ensuring consistency across study design elements (PIP vs protocols vs IBs) 

• Summarising timelines, age groups, endpoints and paediatric-specific safety monitoring 

• Aligning with ICH and EMA templates and regulatory expectations 

• Supporting version control and updates during the regulatory lifecycle 

Even when not drafting a PIP directly, understanding its structure ensures clarity and alignment across related documents. 

Example Scenario 

A company is developing Neuromexa, a new Alzheimer’s therapy. In its PIP submission: 

• It requests a waiver for patients under 2 years old 

• Proposes a deferral for children aged 2–11, until after adult safety data are available 

• Plans a PK/safety study in adolescents (12–17 years) after Phase III completion 

A medical writer might draft the summary table of proposed studies, write the justification for the deferral, and ensure that the PIP aligns with the Investigator’s Brochure and clinical protocols. 

Final Thoughts 

The Paediatric Investigation Plan is more than a regulatory requirement; it’s a commitment to paediatric health. For medical writers, understanding the logic and structure of a PIP enhances our ability to contribute meaningfully to product development, particularly in EU submissions. 

As I continue building my regulatory writing expertise, I recognise the value of the PIP in bridging ethics, science, and planning for paediatric populations. It’s where regulatory strategy aligns with ethical responsibility, and clear, structured writing plays a central role in bridging that gap. 

References 

• European Medicines Agency (EMA). What is a Paediatric Investigation Plan? EMA Website 

• Regulation (EC) No 1901/2006 – Paediatric Regulation. EUR-Lex 

• EMA. PIP Guidance Document: Applications for Product-Specific Waivers EMA Waiver Guide