Friday, January 8, 2010

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


  • 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.

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