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EMEA committee agrees paediatric research investigation plans

The EMEA Paediatric Committee makes progress with the assessment of the first requests for paediatric investigation plans and waivers and continues to refine procedural aspects

The European Medicines Agency's (EMEA) Paediatric Committee (PDCO) has made progress with the assessment of the first requests for paediatric investigation plans (PIPs) and waivers and continued to refine the procedural aspects for the operation of paediatric activities.

PDCO adopted a draft list of waivers covering a number of conditions which do not affect children and for which a paediatric investigation plan will not be required. The drafts will ensure that research in the paediatric population is only conducted to meet their therapeutic needs.

The list is available on the EMEA website for public consultation before the committee progresses to final adoption. According to the paediatric regulations, the EMEA will maintain a complete list of waivers, which will be updated every year and made available to the public.

PDCO also agreed on a proposal on the format and content of the information to be collected by the Member States regarding all existing uses of medicinal products in the paediatric population by January 2009. The proposal will be the basis for an inventory of needs in this population group.

Following the conclusion of the public consultation phase, PDCO finalised the draft implementing strategy for a network of paediatric networks in the EU. The new network aims to bring together the best available scientific expertise in the performance of studies in the paediatric population in the region.

The draft implementing strategy will be sent to the EU Commission and presented to the EMEA Management Board in October 2007. Final adoption is anticipated for January 2008.

The next PDCO meeting is at the end of September 2007 and will involve the appointment of the committee's chair and vice-chair, as well as the adoption of the first requests for modification of proposed PIPs, and/ or PDCO opinions for PIPs or waivers.

10th September 2007

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