EU wants more control of child medication

European Union health ministers today voted to require more regulatory approval for medication used by children.

All drugs that are used regularly by children under 18 will have to pass a paediatric study. Drugs used only by adults will be waived from the requirement.

“More than half the medicines in Europe have not been tested and approved for use in children,” EU Industry Commissioner Gunter Verheugen said in a statement.

Under current rules, only medicines for adults must undergo extensive testing including preclinical tests and clinical trials to ensure that they are safe, of high quality and effective.

The EU said it would provide funding for studies on medicines for children and create a network of trial centres to conduct the research required. The proposal still faces some hurdles before it becomes law, including a reading in the European Parliament, but is expected to enter into force by 2007, the statement said. Verheugen called on the European Parliament and Austria, the incoming EU president, to ensure the new regulation becomes law as soon as possible.