EMA says additional assessments are needed for coated nanomedicines

Published: 2-Sep-2013
Regulatory

Companies should consider their stability, pharmacokinetics and biodistribution, among other things


The European Medicines Agency (EMA) has advised pharmaceutical manufacturers to assess carefully the potential impact of nano-particles integrated into a medicine’s coating.

The agency has published a paper outlining a series of issues that companies should consider regarding nano-coatings. These include their stability, pharmacokinetics and biodistribution; and the potential interaction of the coating with other molecules and resulting consequences for patients.

The paper said that careful consideration should be given to 'the potential impact of the coating on the efficacy and safety profile of the product'.

It added that this information is 'critical for assessing human clinical trials, pre- and post-authorisation manufacturing changes for a coated nanomedicine, and proving the similarity of follow-on coated nanomedicine products'.

EMA warned that in some cases, a nano-coated medicine may generate effects that had not been observed for either the nano-element or the body of the pharmaceutical when examined separately.

'Ongoing research is rapidly leading to the emergence of more sophisticated surface modifications,' the agency added.

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  • EMA European Medicines Agency
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