Paediatric Committee of the European Medicines Agency (EMA) re-elects Dr Dirk Mentzer as its chair

Dr. Dirk Mentzer Source: PEI

Even though more than 100 new medicines have been authorised for children since the paediatric regulation came into force in 2007 and with more than 100 medicines with an existing authorisation for adults, where an indication was added for children, more than half of the medicines used in paediatrics are not authorised for children. This deficit is most significant for newborns where nine out of ten medicines used in newborns are not authorised for treatment of neonates. This means that no clinical trials have been performed for the medical treatment of the children so that only the data for adults are used as a basis for children (off-label). Such an approach, however, is very problematic, since physiological processes differ greatly between children and adults.

For this reason, the Regulation for Paediatric Medicines (Regulation (EC) No 1901/2006) requires the applicant to have a paediatric investigation plan (PIP) approved by the Paediatric Committee of the EMA when applying for a marketing authorisation of a new medicine. In this paediatric investigation plan, the applicant describes how he intends to study the medicinal product in clinical trials in children. If a product is not intended for use in children such as products for the treatment of breast cancer, or if the manufacturer wishes to defer the clinical trials in children, he must justify this as appropriate.

"I am very pleased that Dr Mentzer’s successful work has been confirmed with his re-election as chair. With his great expertise, both in the Paediatric Committee and as head of the Unit Pharmacovigilance of the Paul-Ehrlich-Institut, he assures that tested and authorised medicines are also available for children and adolescents", explains Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut.

"I think the Regulation on Paediatric Medicines is a success because it assures that children are not forgotten when new medicines are developed", as Dr Mentzer emphasises. Previous successes of the Paediatric Committee are described in the first Report of the EU Commission, which was published in June 2013. The EU Commission is planning to publish another extensive report for the end of the year which discusses the socio-economic aspects and the influence of the Paediatric Medicines Regulation on research and marketing authorisations for children. "The PDCO not only paves the way for the clinical development of medicines for children but also encourages the appropriate research in connection with the development of medicines, for example by developing mathematical-statistical models that help calculate the dose/effect relationship of medicines in children."

In the next few years, Dr Mentzer intends to intensify the collaboration with the committees of the EMA responsible for marketing authorisations so as to integrate the experience gained for new medicines in the last few years in regard to their use in children. "Our aim is to introduce considerably more safe and effective medicines for children into the market."

PDCO – Paediatric Committee of the European Medicines Agency (EMA)

The Paediatric Committee (PDCO) is composed of one member each (and one deputy member) per EU member state with five members nominated directly by the Committee for Medicinal Products for Human Use (CHMP). In addition, three representatives from the medical profession and patient advocate organisations are represented in the Paediatric Committee. Members are nominated for three years and they elect the chair from their members. Dr Dirk Mentzer has represented Germany in the Paediatric Committee ever since it was founded in 2007 and was the deputy chair from 2010 – 2013. Since 2013, he has been the chair of the committee.

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