{"id":341,"date":"2026-08-10T15:53:10","date_gmt":"2026-08-10T13:53:10","guid":{"rendered":"https:\/\/www.pqra.gr\/paediatric-investigation-plans-planning-for-the-youngest-patients\/"},"modified":"2026-08-27T11:37:55","modified_gmt":"2026-08-27T09:37:55","slug":"paediatric-investigation-plans-planning-for-the-youngest-patients","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/paediatric-investigation-plans-planning-for-the-youngest-patients\/","title":{"rendered":"Paediatric Investigation Plans: Planning for the Youngest Patients"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>For most new medicines, developing for adults is only part of the obligation. The Paediatric Investigation Plan determines what a company must do for children &mdash; and getting it wrong delays the entire programme.<\/strong><\/p>\n<p>The Paediatric Regulation (EC) No 1901\/2006 requires that, for most new marketing authorisation applications and for certain line extensions of patent-protected products, a company either completes an agreed Paediatric Investigation Plan (PIP) or obtains a waiver or deferral.<\/p>\n<h2>PIP, waiver or deferral?<\/h2>\n<ul>\n<li>A <strong>PIP<\/strong> sets out the studies needed to support use in children.<\/li>\n<li>A <strong>waiver<\/strong> applies where the disease does not occur in children, or where the medicine is likely to be unsafe, ineffective or of no therapeutic benefit to them.<\/li>\n<li>A <strong>deferral<\/strong> allows paediatric studies to begin later &mdash; typically after adult data &mdash; so that adult authorisation is not held up.<\/li>\n<\/ul>\n<p>The Paediatric Committee (PDCO) at the EMA agrees and modifies PIPs, grants waivers and deferrals, and checks compliance.<\/p>\n<h2>The rewards<\/h2>\n<p>Completing an agreed PIP can earn a <strong>six-month extension<\/strong> of the supplementary protection certificate. For orphan medicines, the reward is instead <strong>two additional years<\/strong> of market exclusivity. A dedicated Paediatric Use Marketing Authorisation route exists for developing off-patent products specifically for children.<\/p>\n<h2>Reform is coming<\/h2>\n<p>The EU pharmaceutical legislation reform, which reached political agreement in December 2025, is set to change paediatric development: earlier PIP submission, a more flexible stepwise plan that develops as evidence accrues, and a move toward obligations tied to a medicine&#8217;s mechanism of action &mdash; potentially narrowing some class waivers. The final text is not yet in force, so plan for the direction rather than the detail.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA supports PIP strategy, PDCO interactions, waiver and deferral requests, and compliance across the paediatric lifecycle.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Discuss your paediatric strategy &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>For most new medicines, developing for adults is only part of the obligation. The Paediatric Investigation Plan determines what a company must do for children &mdash; and getting it wrong delays the entire programme. The Paediatric Regulation (EC) No 1901\/2006 requires that, for most new marketing authorisation applications and for certain line extensions of patent-protected [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":354,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[9,10],"tags":[],"class_list":["post-341","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-base","category-regulatory-affairs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Paediatric Investigation Plans: Planning for the Youngest Patients - PQRA<\/title>\n<meta name=\"description\" content=\"For most new medicines, developing for adults is only part of the obligation. 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