EU Paediatric Regulation

The main object of the new EU paediatric regulation starting 26th of January 2007 is to improve the health of children by better regulation of medicines used for children. All available results of paediatric studies and trials should be submitted by marketing authorisation holders to the national competent authorities or to the EMEA before 26 January 2008. Further paediatric studies should be submitted on an ongoing basis within six months of their completion.

About the new legislation

At present, only a small part of medicines used for children are properly studied on them. This means that information is lacking concerning long term safety in growing children

The objectives of the new regulation are

  • to facilitate development and availability of medicines for children aged 0 to 17 years,
  • to ensure that medicines for use in children are of high quality, ethically researched, and authorised appropriately,
  • to improve the availability of information on use of medicines for children without subjecting children to unnecessary trials or delaying the authorisation of medicinal products for use in adults.

Paediatric Committee (PDCO) is a new committee at EMEA which will work on the new regulation. Its main responsibility will be to evaluate Paediatric Investigational Plan (PIP).

Initiatives from pharmaceutical companies are rewarded

The new regulation includes new and old medicines. It includes both rewards, incentives and obligations.

Pharmaceutical Companies are obliged to develop medicines for children. Six months extension of the market exclusivity is given if studies are performed according to a Paediatric Investigational Plan (PIP) –no matter whether the studies leads to paediatric indication or not.

The results of all the studies according to a PIP agreed with PDCO has to be submitted prior to a new market authorisation for new medicines (if not PDCO has decided on a deferral or waiver). A PIP should be submitted as early as possible in the drug development not to delay the authorisation for the medicines in children.

A company can however change a PIP if new important information on the medicine is provided.   

  • A deferral means that studies on children  postponed until more knowledge on the use of medicine in adults are collected.
  • A waiver means that studies on children are not necessary. A waiver can be given if there are safety concerns or if the indication does not exist in children.

Collection of existing information on use of medicines in children will be done in different ways according to the new regulation. This is to avoid unnecessary trials on children.

Submission of data on children for authorised medicines

All available results of paediatric studies should be submitted by marketing authorisation holders to the national competent authorities or to the EMEA before 26 January 2008 according to article 45 in the paediatric regulation. Further paediatric studies should be submitted on an ongoing basis within six months of their completion.

EMEA and CMD (h) has agreed to a list of paediatric studies as a first step. This list will then be used to divide the work on evaluation of these studies in between countries. The name of the MAH should be stated in the list in column named ”subject.” Studied already submitted will not have to be resubmitted.

 
 
 

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