Medical Writing Medical Writing in Paediatrics Preparing the Paediatric Investigation Plan application

Volume 21, Issue 2 - Medical Writing in Paediatrics

Preparing the Paediatric Investigation Plan application


In Europe, sponsors must possess a compliant Paediatric Investigation Plan (PIP) when applying for marketing approval of drugs. The core deliverable is the ‘scientific part of the application’ structured according to the EMA's PIP guideline. The PIP should summarize relevant background information on the disease and drug, and use this to justify a paediatric development programme that covers the entire paediatric population. Depending on the type of drug and the relevance of the disease to the paediatric population, specific quality, safety, and/or efficacy measures may be proposed for all or part of the population. If measures are considered inappropriate for all or part of the paediatric population, then a waiver may be proposed but must be justified. If the paediatric development programme cannot be completed before submission of the adult application, then a deferral of the paediatric measures may be proposed but again this must be justified. In any case, a detailed timetable has to be provided and adhered to for any all measures being proposed. The main challenges for medical writers when writing a PIP are application of the guidance to the drug and disease in hand, and obtaining the appropriate input from the project team.

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  2. European Medicines Agency. Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan. Available from:
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Medical writing in paediatrics: Children and the future
Message from the President
Challenges of paediatric drug development and impact of paediatric legislation
Writing applications for Paediatric Investigation Plans and waivers
Preparing the Paediatric Investigation Plan application
ADHD: A true neurodevelopmental disorder?
Medicines information for patients: Insights into research and practice for medical writers
The MHRA perspective on the new pharmacovigilance legislation
Are stem cells the future of healthcare?
O, safety, quo vadis?
Crowdpower in the era of ‘health 2.0’
Networking effectively: Essential for being successful in business
The moving image and your business
Forgive me for repeating myself: Self-plagiarism in the medical literature
In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
Regulatory Writing
English Grammar and Style
Out On Our Own

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