European Medicines Agency Paediatric Working Party meets for last time ahead of creation of new Paediatric Committee
Press releaseMedicinesPaediatrics
The European Medicines Agency's Paediatric Working Party (PEG) met for the very last time on 25 May 2007, ahead of the first meeting of the new Paediatric Committee on 4-5 July 2007.
The PEG, a working party of the Committee for Medicinal Products for Human Use (CHMP), was first established by the Agency in 2001 as a temporary expert group ahead of the paediatric regulation, which was adopted on 12 December 2006. Dr Daniel Brasseur, who was at the same time chairman of the CHMP, chaired the group and the vice-chair was Dr Kalle Hoppu.
Preparing the groundwork for the paediatric regulation
Over the six-year period the PEG laid the groundwork for the Agency's work in implementing the new paediatric regulation and contributed to the development of paediatric medicines. The group has identified and regularly published paediatric needs in various therapeutic areas.
Contribution to guidance for development and supervision of paediatric medicines
It has also prepared or contributed to a number of key guidance documents, including
- Reflection paper on formulations of choice for the paediatric population
- Guideline on conduct of pharmacovigilance for medicines used by the paediatric population
- Role of pharmacokinetics in the development of medicinal products in the paediatric population
- Investigation of medicines in the neonatal population
The paediatric regulation and EU 7th research framework programme
In addition, the PEG has contributed to the legislative preparation of the paediatric regulation and to its implementation, in particular through the establishment of the priority list of off-patent medicines for studies in children which will be funded through the EU 7th Research Framework Programme.
Working with partners
In achieving its objectives, the PEG has worked closely with learned societies in the paediatric field and has also established contacts with existing research networks of paediatricians in preparation for the development of the European paediatric network under the paediatric regulation.
The Paediatric Committee
The PEG has now ceased its activities, as the paediatric regulation requires the establishment of the Paediatric Committee, a new scientific committee within the EMEA, by 26 July 2007. This Committee will have an essential role in fulfilling the objectives of the paediatric regulation and ensuring that medicines are developed and authorised in Europe for children of all age groups.
Notes
- Regulation (EC) No 1901/2006 of 19 December 2006 on medicinal products for paediatric use is published in OJ L 378, 27.12.2006, page 1. This was amended by Regulation (EC) No 1902/2006, also published in OJ L 378, 27.12.2006, page 20.