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) 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—typically after completion of marketing authorization in adults. This prevents pediatric studies from delaying adult authorization.
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).