{"id":6770,"date":"2026-05-12T12:17:10","date_gmt":"2026-05-12T10:17:10","guid":{"rendered":"https:\/\/mediconomics.com\/glossar\/paediatric-investigation-plan-pip\/"},"modified":"2026-05-12T12:17:10","modified_gmt":"2026-05-12T10:17:10","slug":"paediatric-investigation-plan-pip","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/paediatric-investigation-plan-pip\/","title":{"rendered":"Paediatric Investigation Plan (PIP)"},"content":{"rendered":"

A Paediatric Investigation Plan (PIP)<\/strong> is a development programme reviewed by the European Medicines Agency that describes how the efficacy, safety and appropriate use of a medicinal product in children and adolescents<\/strong> are to be investigated.<\/p>\n

The PIP is a key element of the EU Paediatric Regulation and is intended to ensure that paediatric data are collected systematically\u2014rather than deriving paediatric treatment solely from adult data.<\/p>\n

What is a Paediatric Investigation Plan used for?<\/h2>\n

The PIP defines which studies, formulation development and other measures are required to assess a medicinal product for paediatric age groups.<\/p>\n

Typical objectives include:<\/p>\n

    \n
  • Definition of appropriate age cohorts<\/strong> (e.g. newborns, infants, children, adolescents)<\/li>\n
  • Specification of clinical studies<\/strong> and, where applicable, non-clinical investigations<\/li>\n
  • Development of a child-appropriate dosage form<\/strong> (e.g. syrup, orally disintegrating tablet, dosing aids)<\/li>\n
  • Planning of pharmacokinetic\/pharmacodynamic<\/strong> investigations and safety monitoring<\/li>\n<\/ul>\n

    When must a PIP be submitted?<\/h2>\n

    In the EU, a PIP is generally required when marketing authorisation is sought for a new medicinal product or a new indication and the disease may also be relevant in childhood.<\/p>\n

    The PIP is typically submitted early in development (often before Phase I\/II planning is finalised), as many requirements are time-critical.<\/p>\n

    Who assesses the PIP?<\/h2>\n

    The scientific assessment is carried out by the EMA\u2019s Paediatric Committee (PDCO)<\/strong>. The PDCO may: <\/p>\n

      \n
    • approve<\/strong> the PIP (where applicable, with conditions)<\/li>\n
    • request changes<\/strong> (modification of the plan)<\/li>\n
    • reject<\/strong> it if the rationale or methodology is not convincing<\/li>\n<\/ul>\n

      Deferral and waiver: important exceptions<\/h2>\n

      In many development programmes, exemptions are used:<\/p>\n

        \n
      • Deferral<\/strong>: certain paediatric studies may be postponed (e.g. until more adult data are available).<\/li>\n
      • Waiver<\/strong>: a (partial or full) exemption from the obligation if the medicinal product is not suitable for children or the indication is not relevant in childhood.<\/li>\n<\/ul>\n

        Why is the PIP also economically relevant?<\/h2>\n

        An approved PIP can structure regulatory obligations, but can also trigger incentive mechanisms<\/strong> (e.g. extension of the supplementary protection certificate or additional market exclusivity in certain constellations). At the same time, it affects the cost, timeline and feasibility of the development programme. <\/p>\n

        FAQ<\/h2>\n

        Is a PIP the same as a paediatric study protocol?<\/h3>\n

        No. The PIP is an overarching development programme and may include multiple studies and measures. Individual protocols are more detailed and are developed later. <\/p>\n

        Does the PIP also apply to generics?<\/h3>\n

        Generics are often subject to exemptions; the specific obligation depends on the authorisation pathway and the indication applied for.<\/p>\n

        Can a PIP be amended retrospectively?<\/h3>\n

        Yes. PIPs are often adjusted during development, for example when new data become available or studies are not feasible in practice. <\/p>\n","protected":false},"excerpt":{"rendered":"

        A Paediatric Investigation Plan (PIP) is a development programme reviewed by the European Medicines Agency that describes how the efficacy, safety and appropriate use of a medicinal product in children and adolescents are to be investigated. The PIP is a key element of the EU Paediatric Regulation and is intended to ensure that paediatric data […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6770","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6770","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6770\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6770"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6770"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}