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EMA wants pharma to see commercial potential in paediatric R&D

Publishes list of research needs for children’s cardiovascular medicines

The European Medicines Agency (EMA) has released its first inventory of research needs in children's medicines for consultation, and hopes to highlight commercial possibilities to pharma while helping fill R&D gaps.

Developed by the Agency's Paediatric Committee (PDCO), the first details from the inventory cover cardiovascular medicines for use in children, and sets out where further R&D is needed for each drug.

This mainly includes the need for data on a drug's safety and efficacy for certain age groups, as well as data on specific dose formulations.

Drugs listed include warfarin, propranolol and low molecular weight heparins, all of which are unavailable for or have limited use in children and similar lists for other therapeutic areas will be released for public consultation during 2012 and 2013.

According to the EMA, the aims of the completed inventory include an opportunity for companies to identify areas of business development, where they could expand a drug's use.

In addition, the PDCO will also be able to judge the need for medicines and studies when assessing draft paediatric investigation plans, waivers and deferrals, while healthcare professionals and patients will have access to information to support their decisions on medicines.

The inventory is based on a report on the survey of all paediatric uses of medicinal products in Europe completed by the PDCO in December 2010.

The first list of research needs in cardiovascular medicines will be open for comments until October, 30. Following this consultation period, the PDCO will review comments and amend the document where required before publishing the final version of the list.

10th September 2012

From: Research



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