E-DRUG: UK launches child medicine initiative despite EU delays
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[E-drug reported earlier that the new EU Commission did not find the money to pay for an EU-wide child medicines initiative. The UK (which had announced similar plans earlier) has now decided to start the project anyway. Copied as fair use from ERA news. WB]
UK launches child medicine initiative
The UK has launched a new initiative to encourage the development of medicines specifically for children. Given that European legislation in this field is unlikely to be adopted before 2006, (ERA News No 145, p 6), the UK decided to take the bull by the horns and to do its part in making the industry more aware of the issue.
The Department of Health recognises that there is a lack of incentive for companies to research and develop medicines solely for children and that most paediatric medicines are actually designed for adults. Its strategy has three main goals: to see an increase in appropriately labelled and formulated medicines for children; to provide useful information to prescribers, carers and patients; and to make it easier to conduct paediatric clinical trials in the UK.
As part of the short-term strategy, the UK's Medicines and Health products Regulatory Agency (MHRA) has decided to offer sweeteners to encourage companies to include child-safety information in the summary of product characteristics. It will give free paediatric scientific advice and will waive application fees.
In the longer term, the MHRA also plans to tackle the problem of medicines that have been discontinued for child use but remain licensed on the market indicated for adults. The agency will write to companies, which have announced their intention to discontinue such a product, alerting them of the therapeutic need in children for the medicine concerned. It will also ask firms how they intend this need to be met once the drug in question is no longer indicated for use in children.
The MHRA will also look abroad for paediatric medicines that are not available in the UK and are licensed in countries outside the European Union with a similar regulatory system to the UK. It will then issue invitations to the manufacturers asking them to submit an application for authorisation.
While there is currently no legislative obligation for companies to develop medicines for particular groups within the patient population, this is set to change once the proposed EU Regulation comes into force. This will increase the quality (and indeed the quantity) of research done in children's medicine, as well as providing incentives and obligations targeted at increasing drugs that are licensed specifically for children.
Full Title: ERA NEWS - European Regulatory Affairs
FILED 9 September 2004 COPYRIGHT 2004 PJB Publications Ltd
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