A special commission to advise on approval applications for pharmaceuticals aimed at children and adolescents has been set up at the German regulatory authority, BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte).
The eight-member Commission for Pharmaceuticals for Children and Adolescents, which draws on expertise from the fields of child and adolescent medicine and psychiatry as well as biometrics, will work with BfArM and the Paul Ehrlich institute (the German federal agency for sera, vaccines and blood products) on assessing approval applications for medicines specifically geared to use in children and adolescents.
The new commission will also advise on approval applications for other medicines that may be used in these populations, and on the conditions under which pharmaceuticals not currently approved for child and adolescent use could be extended to these groups. In addition, the commission will contribute to the inventory of therapeutic needs for children and adolescents to be established by the Paediatric Committee, a new unit within the European Medicines Agency (EMEA), under the European Union’s forthcoming regulation on medicinal products for paediatric use.
Aim to improve drug safety
The legal basis for the German initiative was a new paragraph in the 12th amendment to the national medicines law, introduced in July 2004 with a view to improving drug safety for children and adolescents. This was two months before the European Commission adopted a proposal for a regulation on medicinal products for paediatric use, which sprang from the observation that between 50% and 90% of all medicines used in the paediatric population had never been specifically studied or authorised for this purpose.
The paediatric regulation, which is expected to come into force next January, aims to stimulate the development of properly researched medicines for children without imposing undue burdens on new drugs for the adult population. It includes incentives for pharmaceutical manufacturers, such as a six-month extension to a product’s supplementary protection certificate for meeting the requirements of an agreed paediatric investigation plan or a one-year extension of data exclusivity for a new paediatric indication of an existing medicine.