Active for safe medicinal products for children - Dr Dirk Mentzer becomes chair of the EU Paediatric Committee

Dr. Dirk Mentzer Source: PEI

The figures speak for themselves: In children, around 20 per cent of the medicinal products used in an outpatient setting and 50 per cent in hospitals are still used off label, i.e. without a marketing authorisation for the appropriate age group. The Paediatric Regulation (Regulation (EC) No 1901/2006) is designed to remedy this situation. According to this Regulation, it is compulsory for the applicant to submit a "Paediatric Investigation Plan" (PIP) which must be authorised by the Paediatric Committee of the EMA when the applicant applies for a marketing authorisation for a new medicinal product. The PIP must contain information as to how the applicant will test his active substances in paediatric clinical trials. If a medicinal product is not designed for paediatric use, for instance, a product for the treatment of Alzheimer's, or if the manufacturer wishes for the granting a deferral of the paediatric clinical trials, he will be obliged to justify this accordingly.

"With its scientific work in the Paediatric Committee, the Paul-Ehrlich-Institut contributes to guaranteeing that tested medicinal products in high quality are also increasingly available for children and young people", Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut explained.

As from 2005, Dr Dirk Mentzer already was a member of the Paediatric Working Party of the EMA, the precursor of the Paediatric Committee. Up to his election as chair in September this year, he was the German member, and as from 2010, he was elected vice-chair of the Paediatric Committee. "As a paediatrician, I had to treat my young patients with medicines which were not tested for this age group. I'm glad I can use my work in the PDCO as a contribution assuring that we will have safe and effective medicines for children, too, in future", said Mr Mentzer.

Previous successes in the Paediatric Committee have been impressively described in the first report of the EU Commission and published in June 2013.

The Paediatric Committee is composed of one member from each EU member state with five members designated directly by the Committee for Human Medicinal Products (CHMP). In addition, three representatives each from the medical profession as well as patient organisations are represented in the Paediatric Committee. Members are designated for three years each and elect one member out of their group of members as their chair.

Further information:

Paediatric Committee elects new Chair and Vice-Chair

The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.

Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.

The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organisation, European Medicines Agency, European Commission, Council of Europe etc.).

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