EMEA calls for paediatric medicines guidelines

Published: 1-May-2003


The European Agency for the Evaluation of Medicinal Products (EMEA) has released a detailed paper proposing that guidelines are drawn up for the development and application of medicines designed for use by children. It suggests that a Paediatric Pharmacovigilance Guideline is written by the EU's CPMP Pharmacovigilance Working Party 'to underpin' other strategies now being considered by EU regulators.

Issues that should be covered by the guidelines, said the paper, 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, said the paper, notably 'the benefit/risk relation of vaccines in healthy children, especially when the incidence of infectious disease in the target population is low.'

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