Medicines for Children - EU Pediatric Regulation - EMEA

In the previous communication, information pertaining to EU PIP was provided to the readers. A bit more about the PIP Regulation - yes, it is new - entered into force in the EU on 26 January 2007.

The objective of the Pediatric Regulation is to improve the health of children in EU by:

• facilitating the development and availability of medicines for children aged 0 to 17 years
• ensuring that medicines for use in children are of high quality
• ethically researched
• authorized appropriately
• quality-controlled
• quality-assured
• improving the availability of information on the use of medicines for children

without:

• subjecting children to unnecessary clinical studies and clinical trials
• delaying the authorization of medicines for use in adults.

The Pediatric Regulation dramatically changes the regulatory environment for pediatric medicines in EU.

In the next communication, I will provide opinion and key aspects of the changes impacting the regulatory environment for pediatric medicines in EU.