EMA: New Guideline on Development of Medicines for Paediatric Use

The European Medicines Agency has recently published a draft guideline on pharmaceutical development of medicines for paediatric use.

In January 2007 Regulation EC No 1901/2006 (the "Paediatric Regulation") entered into force. As a result of this Regulation, the number of paediatric formulations that the pharmaceutical industry will have to develop to support their clinical trials will increase. It is expected that the number of medicines applying for a marketing authorisation for paediatric use will increase as a result. Therefore, the existing regulatory documents need to be supported by specific regulatory guidance on the pharmaceutical development of medicines for use in children between birth and 18 years of age.

Please see the Guideline draft for further information.

Comments related to this draft should be provided using this template. The completed comments form should be sent to qwp@ema.europa.eu.

Please note that the deadline for comments for this draft guideline is 31 December 2011.