New EU Approach to Medicines for Children Reviewed by Hogan & Hartson

This article examines the new EU legislation on medicines for children. The Paediatric Medicines Regulation aims to increase the development of medicines for treatment of children, to ensure research and to improve information available in this area. All pharmaceutical companies seeking to sell their medicines in the EU have an interest in this legislation, whether or not the products are intended to treat children. It is also of interest to pharmaceutical companies seeking to develop off-patent medicinal products to treat children.

The Regulation imposes an extensive system of requirements on companies and provides for penalties for non-compliance. However, it also offers rewards and other incentives. The Regulation entered into force on 26 January 2007, although some of its provisions enter into force at a later date.

Adoption of the Regulation is expected to lead to increased assurance concerning the quality, safety and efficacy of medicinal products prescribed for paediatric use. However, it remains to be seen whether the industry will consider the benefits for which the Regulation provides adequately compensates for the additional studies that they will be required to undertake and costs involved.

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