Paediatric investigation plans, waivers and modifications

A paediatric investigation plan (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 European Medicines Agency's Paediatric Committee (PDCO). This Committee is responsible for agreeing or refusing the plan. The Paediatric Regulation requires these plans to be submitted to the Agency early, wherever possible.

The normal development of a medicine requires that various studies be performed to ensure its quality, safety and efficacy. The development plan can be modified at a later stage, as knowledge increases. Modifications can also be made if the applicant encounters such difficulties with the implementation of the plan, which render it unworkable or no longer appropriate.

• PIPs include a description of the studies and of the measures to adapt the medicine's formulation to make its use more acceptable in children, such as use of a liquid formulation rather than large tablets.
• PIPs cover the needs of all age groups of children, from birth to adolescence.
• PIPs defines the timing of studies in children compared to adults.

In some cases, studies can be deferred until after the studies in adults have been conducted. This ensures that research in children is done only when it is safe and ethical to do so. Even when studies are deferred, the PIP will include details of the paediatric studies and their timelines.

As some diseases do not affect children (for example Parkinson's disease), the development of medicines for these diseases should not be performed in children. In these cases, a PIP is not required and it will be waived. For more information on the classes of diseases subject to waivers, see class waivers. 

Table of contents

• General guidance
• Templates and forms
• Useful documents
• Deadlines (please note that the published date refers to the last acceptable day of receipt of electronic documents (via Eudralink or CD/DVD) and meeting dates

General guidance

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Templates and forms

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Useful documents

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Deadlines (please note that the published date refers to the last acceptable day of receipt of electronic documents (via Eudralink or CD/DVD) and meeting dates

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