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Artikkel18 jaanuar 2019

Mapping available standards against regulatory needs of nanomedicines

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The JRC study shows that relevant standardised methods for the characterisation of nanomedicines are still lacking
© EU, 2018

JRC scientists analysed the availability of suitable standards for the regulation of nanomedicines. With this they aim to anticipate needs for test development and standardisation, to support a smooth translation of promising health products to the market.

An unclear regulatory environment can contribute to uncertainties for product developers and regulators when it comes to the regulatory approval of innovative products for clinical applications.

Since the availability of suitable standardised methods is a key element in such regulatory processes, JRC scientists have mapped available standards against information requirements addressing nano- specific properties that are known to have an impact on the quality and safety of nanomedicines.

As initial step, information needs related to the physicochemical and biological characterisation of nanomedicines were collected from publically available guidance documents, opinions and workshop proceedings as well as from results obtained from three surveys launched by the JRC within various communities.

The following mapping exercise of information requirements against available standardised methods demonstrated that only few analytical methods are existing for the characterisation of nanomedicines.

The gap analysis demonstrated that in particular methods related to the assessment of interactions of nano-enabled health products with the immune system are still lacking.

Furthermore, the correct detection and quantification of nanomaterials in biological tissues is essential to investigate the biological fate and accumulation of nanomaterials in tissues and organs. This study revealed that relevant standardised methods are still lacking.

Read more in: Halamoda-Kenzaoui B, Holzwarth U, Roebben G, Bogni A, Bremer-Hoffmann S. Mapping of the available standards against the regulatory needs for nanomedicines. WIREs Nanomed Nanobiotechnol. 2018; e1531, doi.org/10.1002/wnan.1531

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Mapping of the available standards against the regulatory needs for nanomedicines

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18 jaanuar 2019