EMEA DRAFTS NEW GUIDELINES FOR PAEDIATRIC MEDICINES

The European Medicines Agency (EMEA) has begun a six-month consultation period for a draft guideline concerning the safety of medicines in children. This is the first EMEA guideline that will focus exclusively on drug safety in the paediatric sector. The EMEA will be consulting on adverse drug reactions in children, as well as the possibility of launching a number of studies tracking the long-term safety of medicines in children.

According to the European Commission, over 50% of drugs prescribed to treat children are 'off-label', meaning the drug is being used for an indication other than that for which it was originally approved. There is a possibility that 'off label' drug use may increase the occurrence of adverse reactions. This is potentially serious as current systems to detect adverse drug reactions are designed for adults and therefore may not be as suitable for children, who differ physiologically. The EMEA guideline aims to strengthen the drug vigilance system for all medicines taken by children.

In 2004, the European Commission proposed new legislation for the research, development and authorisation of paediatric medicines. The EMEA guideline on pharmacovigilance is designed to work in conjunction with the new regulations.