EC guideline on facilitating applications for pediatric investigation plans

The European Commission has published a revised guideline on applications for pediatric investigation plans, or PIPs, in the Official Journal of the European Union. The new guideline is expected to facilitate the application process. It is intended for all medicines developers.

Since the European Pediatric Regulation came into force in 2007, pharmaceutical companies have had a legal obligation to develop plans to evaluate medicines in children (known as pediatric investigation plans) as part of the development of all new medicines, unless they obtain an exemption (known as a waiver). In some cases, a similar obligation also applies to medicines that are already authorized in the European Union.

The first guideline describing the format and content of applications for paediatric investigation plans was released in September 2008. The Commission has conducted a review of this guideline to take into account experience gained as well as feedback received from medicines developers. The text of the guideline is available in all EU languages.