Pediatric investigation plan

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.

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