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.
The new guideline is applicable as of today. However, the European Medicines Agency (EMA) will continue to accept paediatric investigation plans that have been prepared in accordance with the previous guideline until the end of 2014. The EMA will update its set of documentations related to PIPs, including templates, application forms and questions and answers, to reflect these changes by the end of October 2014.
The EMA’s Paediatric Committee (PDCO) reviews all applications for PIPs and waivers and issues an opinion on the clinical studies, pharmaceutical forms and tests that must be performed in children.
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- Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies
- European Commission: Medicines for children - major developments