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New initiative to develop medicines for children

  • Published date:
    17 August 2004

Most medicines are designed for and tested on adults but are widely prescribed for children. The evidence shows that children and adults respond very differently to medicines and that a treatment which is effective in adults may not be as suitable for children.

These new plans will encourage manufacturers of medicines to research and develop medicines geared to the needs of children. They will also make sure prescribers have better information about the impact of medicines on children.

The new paediatric medicines strategy includes:

  • strongly encouraging companies to provide much better paediatric clinical trial data for new and current medicines;
  • provide better information on the use of medicines on children in patient information leaflets
  • publishing for the first time, a separate British National Formulary for Children;
  • investing part of the additional £100 million announced in the Budget to promote research into medicines for children through new research networks which will be coordinated by the UK Clinical Research Collaboration.

Lord Warner said:

"Until now there hasn't been enough emphasis on developing medicines specifically for use in children, and the UK has led the way in pushing for change in this area.  Work is in progress on a British National Formulary for Children and we provide funding for its publication and distribution as soon as it is ready.  I want the new strategy that I have announced today to give a strong message to pharmaceutical companies to focus on the needs of children when developing new medicines.  Health professionals need the latest information so that they can make the right choices about the medicines and treatments for their younger patients, and that is why the new British National Formulary for Children is so important".

Professor  Rosalind Smyth, Chair of the Committee on Safety of Medicines Paediatric Working Group, said:

"These plans have the potential to make a real difference for children, parents and prescribers by making sure that existing and new medicines are tailored to the needs of children. Children have the right to the same standards for medicines as adults and this strategy is another step towards achieving this".

Notes to editor

2. The CSM is an independent Committee of experts that advises Government on the safety, quality and effectiveness of medicines, including vaccines. It is also responsible for encouraging the collection and investigation of reports on suspected adverse reactions to medicines already on the market. Professor Rosalind Smyth is chairman of the CSM  paediatric working group which was established in 1999 to advise the CSM on paediatric issues.  The MHRA is the executive arm of the UK's Drug Licensing Authority and is responsible for all aspects of the regulation of medicines in the UK.

3. The UK Clinical Research Collaboration (UKCRC) was established in June 2004.  Its task is to speed up the development of new medicines and treatments from the laboratory to the patient's bedside, by expanding the number and range of clinical trials, using the cancer research networks as a model.  The acting chief executive is Dr Liam O'Toole.  It is chaired by the Director of R&D of the Department of Health.

4. The draft Commission proposal for an EU Regulation on medicines for paediatric use can be found at http://pharmacos.eudra.org/F2/home.html or click on the above link.

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