{"id":6700,"date":"2025-09-03T11:51:34","date_gmt":"2025-09-03T09:51:34","guid":{"rendered":"https:\/\/mediconomics.com\/glossar\/pediatric-investigation-plan\/"},"modified":"2025-09-03T11:51:34","modified_gmt":"2025-09-03T09:51:34","slug":"pediatric-investigation-plan","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/pediatric-investigation-plan\/","title":{"rendered":"Pediatric Investigation Plan"},"content":{"rendered":"<p>The Pediatric Investigation Plan (PIP) is a document approved by the EMA (Paediatric Committee, PDCO) that describes how a medicinal product is to be investigated in pediatric patient populations. It is mandatory for all new medicinal products seeking EU marketing authorization, in accordance with Regulation (EC) No 1901\/2006 (Pediatric Regulation). <\/p>\n<p>Two important exemptions are: (1) Waiver: Complete exemption from the PIP requirement when the medicinal product is intended for a condition that exclusively affects adults (e.g., age-related diseases), or when the product is expected to be ineffective or unsafe in children. (2) Deferral: Pediatric studies must be conducted but may be postponed to a later time\u2014typically after completion of marketing authorization in adults. This prevents pediatric studies from delaying adult authorization.  <\/p>\n<p>Compliance with the approved PIP is a prerequisite for EU marketing authorization. Upon compliance, companies receive a 6-month extension of the Supplementary Protection Certificate (SPC). For CROs conducting pediatric studies, special ethical and operational requirements apply (e.g., weight-based dosing, age-appropriate formulations, specific informed consent forms for legal guardians).  <\/p>\n<p><a href=\"https:\/\/mediconomics.com\/glossary\/\">Back to overview<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Pediatric Investigation Plan (PIP) is a document approved by the EMA (Paediatric Committee, PDCO) that describes how a medicinal product is to be investigated in pediatric patient populations. It is mandatory for all new medicinal products seeking EU marketing authorization, in accordance with Regulation (EC) No 1901\/2006 (Pediatric Regulation). Two important exemptions are: (1) [&hellip;]<\/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-6700","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\/6700","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\/6700\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6700"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6700"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}