Medicines for children
Tasks
Many medicinal products that are administered to children have not been tested sufficiently in children and are therefore not licensed for paediatric use. Thus, the appropriate dosage, i.e. one that is both efficacious and safe at the same time, is not known. In addition to this, pharmaceutical forms suitable for children are often lacking. Nevertheless, paediatricians frequently have no other alternative than to administer medicinal products to children that have actually only been tested sufficiently in adults. The so-called "Paediatric Regulation" which aims at improving drug safety in children and adolescents has been in force since 2007. The BfArM is significantly involved in this important task and is active in several committees for this purpose both on national and international levels.
On the national level, the commission for paediatric medicinal products ("Kommission für Arzneimittel für Kinder und Jugendliche", KAKJ) which is consulted for each national licensing decision on paediatric medicinal products was installed at the BfArM.
The Paediatric Committee of the European Medicines Agency assesses and adopts opinions on the paediatric investigation plans and monitors adherence to the specifications.
On the following pages you will find further information on the KAKJ and the two "paediatric procedures" newly introduced in 2007 by the Paediatric Regulation: the paediatric investigation plan and the paediatric worksharing procedure.
PUMA (Paediatric use marketing authorisation)
The Paediatric use marketing authorisation (PUMA) is a new type of marketing authorisation.
PUMA can be used for each already authorised medicinal product in adults. PUMA will utilise existing marketing authorisation procedures but is specified for medicinal products developed exclusively for use in children. This includes paediatric indications in all or subsets of the paediatric population and / or the development of appropriate strength, pharmaceutical form or route of administration. The development has to be in line with the agreed PIP by the PDCO.