Facilitating applications for paediatric investigation plans
European Commission's guideline is applicable as of today
The European Commission has published a revised guideline on applications for paediatric 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 Paediatric Regulation came into force in 2007, pharmaceutical companies have had a legal obligation to develop plans to evaluate medicines in children (known as paediatric 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 authorised in the European Union (EU).
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.
Amongst other elements, the new guideline:
establishes key elements that should be included in paediatric investigation plans,
introduces increased flexibility into the application process,
incorporates new study concepts, such as extrapolation of results and modelling,
clarifies requirements for the compliance check.
The text of the guideline is available in all EU languages.
European Medicines Agency decision
of 8 August 2013
on the agreement of a paediatric investigation plan and on the granting of a deferral and on the
granting of a waiver for naltrexone (hydrochloride) / bupropion (hydrochloride) (EMEA-001373-PIP01-
12) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council
This Decision does not constitute entitlement to the rewards and incentives referred to in
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