Paediatric Investigation Plan (PIP)


PIP tips


Dr Hession has a special interest in writing and advising on the EU paediatric investigation plan (PIP) and waiver and deferral requests.

The PIP is a key element in the EU Paediatric Regulation. It is a plan for adequately defining the efficacy and safety of most medicinal products across all paediatric age groups (namely preterm neonates, term neonates, infants and toddlers, children (aged 2-11 years) and adolescents) in conditions related to all proposed and approved indications.

The Paediatric Committee (PDCO) is the body within the European Medicines Agency (EMA) responsible for overseeing the requirements of the Paediatric Regulation. The PDCO may grant a waiver from developing a PIP for certain (or all) conditions and/or certain (or all) paediatric age groups, and/or a deferral of the start or completion of all or some of the studies (or any other measures) in the PIP. The PDCO grants class waivers for some classes of drugs that are used to treat conditions only occurring in adults, e.g. Alzheimer's disease. In all other cases, waivers must be applied for on a product-specific basis.

Summaries of two meetings on the Paediatric Regulation, written by Dr Hession, have been published in Regulatory Rapporteur:

Based on the latter article, and work on numerous PIP/waiver applications since their inception in 2007, Dr Hession has compiled a list of tips on how to write and revise the document to achieve a successful outcome.


PIP tips

General

Electronic form (including Part A)

Part B – Overall development of the medicinal product

Part C – Applications for product-specific waivers

Part D – Paediatric investigation plan

Part E – Applications for deferrals

Assessment process

Post-opinion processes


General


Electronic form (including Part A)


Part B – Overall development of the medicinal product


Part C – Applications for product-specific waivers


Part D – Paediatric investigation plan


Part E – Applications for deferrals


Assessment process


Post-opinion processes


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