European parliamentarians voted through on Thursday new rules to develop safer medicine for children.

More than half the medicines taken by children in Europe have never undergone testing or clinical trials specifically for their age group, the European Commission says.

Almost none, it says, are authorised for babies.

The new rules could be adopted by EU health ministers on Friday, paving the way for the legislation to come into force in January.

The legislation will oblige firms to submit a "paediatric investigation plan" outlining a research and development programme to guarantee information about new medicines.

The rules will also ensure there is adequate data about dosages. Too much medicine can increase the risk of side-effects or death and too little can render treatment useless.

Currently, many children rely on adult medicines which are given in smaller doses without their effects on the young being fully understood.

"It is unbelievable in 2006 that our children do not have therapies which are adapted to their needs. But it is a reality," said French Member of the European Parliament Francoise Grossetete.

"Thanks to this European text, we have brought together all the necessary conditions to create paediatric medicines," said the deputy, who was rapporteur on the legislation for the assembly.

The rules cover medicines under development and not yet authorised, authorised medication with patents and authorised products not covered by intellectual property rights.

Drug companies which implement the rules for existing medicines will receive the incentive of a six-month extension on their patents.

Only those firms meeting strict standards will be able to market such products for infants, the parliament said.

Particularly worrying, Grossetete said, is a lack of information about drugs for severe diseases such as those used to treat cancer or HIV, the virus that causes AIDS.

Austria, which holds the EU's rotating presidency until the end of the month, welcomed the vote.

"This compromise paves the way for the greatest possible safety in treatment of children with pharmaceuticals in the future," said Austrian Health Minister Maria Rauch-Kallat.

The Greens group in parliament also welcomed the vote but said some of the legislation was a gift to the pharmaceutical industry.

"It is baffling why the pharma industry should be so disproportionately rewarded for doing what it should have done all along," said German MEP Hiltrud Breyer, a member of the group's environment committee.

"Despite the fact the pharmaceutical industry is already one of the most profitable sectors, national health budgets will now have to subsidise it to assess medicines for paediatric use," she said in a statement.

The industry also took a caning from the socialists bloc.

"The pharmaceutical industry has a share of responsibility for having barely reacted to the therapeutical needs of children because it thinks they don't bring in enough money," said French deputy Anne Ferreira.

EU Enterprise and Industry Commissioner Guenter Verheugen said he was hoping companies would do more than the strict minimum.

"I'm expecting to see the pharmaceutical industry will go further than simple economic and financial criteria and do a lot more in this particular sector," he told reporters after the vote.

The rules may be ready to enter force on January 1, 2007, he said.

"The legislative process is almost over, there are only a few details to finalise," said Verheugen.