EMEA TO IMPLEMENT NEW PEDIATRIC REGULATIONS

As one of its main priorities for 2007, the European Medicines Agency (EMEA) will implement new regulations on pediatric medicines this Friday. The new regulations aim to:

• Stimulate R&D of medicines for use in children;
• Ensure that drugs used to treat children are properly tested; and
• Expand the availability of information on pediatric medicines.

The EMEA also plans to establish a new pediatric committee, which will be responsible for reviewing pediatric investigation plans and granting pediatric waivers.

The committee will also work with EU member states to establish an inventory of therapeutic needs of children, so that focus can be directed at the research, development and approval of drugs in areas of unmet medical needs.

The new regulations, published in the Official Journal of the European Union Dec. 12, 2006, and scheduled to go into effect Jan. 26 can be viewed at eur-lex.europa.eu/LexUriServ/site/en/oj/2006/
l_378/l_37820061227en00010019.pdf.