In order to face this urgent problem, the European Paediatric Regulation entered into force in 2007 with the main aim to facilitate the development of medicines for use in the paediatric population, ensuring that drugs used in paediatrics are appropriately authorised and the information available on the use of medicinal products in the various paediatric populations is improved.
In order to bring safe and efficacious medicines for children to the markets, the Regulation has included provisions for the public funding of research on off-patent medicines leading to Paediatric Use Marketing Authorisations (PUMAs). In order to ensure that these public funds were directed into research on medicines with the highest need in the paediatric population, the European Medicines Agency’s Paediatric Committee adopted a list of off-patent drugs for which studies are required. Accordingly, the European Commission Seventh Framework Research Program launched several calls with reference to the development of off-patent medicinal products for the paediatric population.
In response to this mandate and to Call 4.2 “Responding to EU Policy Needs / HEALTH.2013.4.2.-1: Investigator-driven clinical trials for off-patent medicines using innovative, age-appropriate formulation and/or delivery systems for use in children”, the CloSed project has been selected for funding. The project’s main goal is to develop a parenteral age-appropriate formulation of clonidine, a drug that has been included in the 2012 EMA Revised Priority List for Studies into Off-Patent Paediatric Medicinal Products.