As of 2007, a Pediatric Investigation Plan (PIP) is mandatory for all newly authorized medicinal products. A PIP is part of the development of a medicinal product potentially used in children and should be agreed with the EMA and the PDCO and complied with, before your Market Authorization Application.
Bronsing Life Science Consultancy:
- authors your PIP in compliance with EC Regulations 1901/2006 and 1902/2006
- applies for waivers, where applicable
- requests deferrals, where applicable
Is my product eligible for a waiver?
If your drug has no indication for conditions that affect children, for example, an anti-Alzheimer agent, or if the product is considered unsafe/ineffective in children, you can request a waiver from the PIP-requirement.
In which case could I request a deferral?
You could request a referral if you intend first to develop the product in adults and delay the development in children until a later date, for example, because the development in children would take longer.