The need for new guidelines for developing medicines for children has resulted from the entry into force in January 2007 of EU Regulation EC No 1901/2006 (the ‘Paediatric Regulation’), whose objective is to improve the health of children in Europe by facilitating the development and availability of children’s medicines, ensuring they are of high quality and improving the availability of information on their use. This will mean a lot of new rules for the pharmaceutical industry, and the number of medicines applying for a marketing authorisation for use in children will also grow. Existing regulatory documents will need to be supported by specific regulatory guidance on the development of medicines for use in children up to the age of 18.
The document is available for consultation at the EMA website until 31 December 2011.
In addition to this, at the Patients and Consumers Working Party meeting on the 12th of September, EMA launched the new European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA). Enpr-EMA will be comprised of research networks, investigators and centres with recognised expertise in the performance of children’s clinical studies. It will facilitate studies in order to increase the availability of medicinal products authorised for use in the paediatric population.
You must be logged in to post a comment.