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Better medicines for children: EU Commission initiative to get best and safest treatments for children Part 4 (Teacher: Michael)

Medicines available in Europe frequently not include information on safe and effective use in paediatric populations. This, in turn, says the document, leads to the use of unauthorised medicinal products and/or medicines used outside their approved terms "off-label" and may result in significant risks, including lack of efficacy and/or unexpected. results, that might even fatal.

The initial process of providing a remedy to this situation can traced back to 1997 when a round table organised by the EU Commission in the premises of the European Agency for the Evaluation of Medicinal products. The following year the Commission supported the need for international discussion of the performance of clinical trials in children and an International Conference on Harmonisation guideline adopted in July 2000.

In December 1999 the Regulation on Orphan Medicinal Products adopted.

Directive 2001/20/EC on Good Clinical Practice, adopted in April 2001, also takes into account some specific concerns of performing clinical trials in children.

However, says the EU Commission, "there is currently no legal provision for obliging these studies to performed if the company does not present the product for use in the paediatric population."

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