The Pharmaceutical Journal
Vol 270 No 7240 p356
15 March 2003

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European Agency for the Evaluation of Medicinal Products (www.emea.eu.int)

Guideline proposed for children's medicines

Proposals for guidelines on the development and monitoring of medicines intended for use by children have been put forward by the European Agency for the Evaluation of Medicinal Products.

It has suggested that a paediatric pharmacovigilance guideline be written by the Committee on Proprietary Medicinal Products' pharmacovigilance working party. It will be designed to underpin other strategies currently being considered by EU regulators.

Issues that the paper says should be covered include data collection and management, the detection of potential safety problems (especially for orphan drugs), and laboratory investigations.

Special attention should be paid to children's vaccines, the paper adds, notably concerning the relationship between risk and benefit in healthy children, especially when the incidence of infectious disease in the target population is low.

The aim of the guideline will be to address possible differences in the efficacy and safety of medicines in children and adults. Few data are available relevant to children when medicines are authorised.