EMEA CONSULTING ON A DRAFT GUIDELINE ON PHARMACOVIGILANCE FOR MEDICINES USED IN CHILDREN

The European Medicines Agency (EMEA) has launched a six-month consultation period on a draft guideline on the conduct of pharmacovigilance for medicines used by the paediatric population, children from birth to 18 years of age. This is the first guideline to focus exclusively on the issues of safety of medicines in children. The EMEA is consulting not only on reporting of adverse drug reactions in children, but also on the possible need for studies designed to follow the long-term safety of medicines in children.

Medical News Today (http://www.medicalnewstoday.com/medicalnews.php?newsid=29059)