“We were all children once. And we all share the desire for the well-being of our children, which has always been and will continue to be the most universally cherished aspiration of humankind.”
Kofi Annan
Need help Navigating the PIP process?
Kinesys can shepherd you through this complex and lengthy process, advising on strategy, writing the PIP, waiver or deferral documentation, submitting and supporting you through the review, and organising and attending EMA/PDCO meetings.
With our knowledge and experience of working with the Paediatric Committee we add efficiency and value, substantially contributing to a successful outcome.
Kinesys also has experience of successfully navigating paediatric applications to the FDA.
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Background to Paediatric Plans
Quality medicines need to be available to children of all ages, and to that end the EMA requires an approved Paediatric Investigation Plan to be in place before submission of a Marketing Authorization Application.
The Paediatric Regulation entered into force in the European Union on 26 January 2007 (Regulation EC 1901/2006) and its objective is to improve the health of children in Europe by:
The EMA Paediatric Committee (PDCO) is responsible for assessing the Paediatric Investigation Plan (PIP) which should be prepared ideally after Phase 1 clinical trials. Its approval is essential for the initial MAA to pass validation.
- Facilitating the development and availability of medicines for children aged 0 to 18 years
- Ensuring that medicines for use in children are of high quality, ethically researched, and authorised appropriately
- Improving the availability of information on the use of medicines for children without subjecting children to unnecessary trials, and without delaying the authorisation of medicines for use in adults.
The EMA Paediatric Committee (PDCO) is responsible for assessing the Paediatric Investigation Plan (PIP) which should be prepared ideally after Phase 1 clinical trials. Its approval is essential for the initial MAA to pass validation.