EMEA releases guidance on child medicines

Published: 20-Oct-2006

The European Medicines Agency (EMEA) has released detailed guidance on the development and manufacture of children's medicines (http://www.emea.eu.int/pdfs/human/regaffair/30582106en.pdf).


The European Medicines Agency (EMEA) has released detailed guidance on the development and manufacture of children's medicines (http://www.emea.eu.int/pdfs/human/regaffair/30582106en.pdf).

An EMEA 'reflection paper' on 'formulations of choice for the paediatric population' covers dosage, excipients, taste, smell, texture, modified release preparations and dose delivery devices.

The guidelines note: 'There is only limited knowledge available' on these topics, admitting that the development of paediatric formulations, especially for the very young, 'can be challenging'.

Special focus is given on the age children can safely swallow solid medicines, noting there are 'significant inter-patient differences' regarding children aged around six. It says manufacturers need to pay special attention to dosages, given that these 'can vary 100 fold' throughout childhood.

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