Regulations of Nanomedicines

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Over the last three decades many first-generation nanomedicines have successfully entered routine clinical use. It is important for medicines regulatory agencies to consider the mechanisms needed to ensure safe introduction of ‘follow-on’ nanomedicine products, ‘nanosimilars’.

Drug regulators need to ensure that ‘next’-generation nanomedicines enter clinical development and consequently the market in a safe and timely way for the benefit of public health.

In Europe the responsible agency for the regulation of nanomedicine is the European Medicine Agency (EMA) as well as national regulatory agencies of each member states.


European Medicines Agency's scientific guidelines on nanomedicines:



European Medicines Agency's Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices:

This Guidance addresses the use of nanomaterials in medical devices regarding specific aspects that need to be considered in the safety evaluation of nanomaterials and it should be considered in conjunction with the ISO 10993-1:2009 standard 'Biological evaluation of medical devices'. The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials, in view of the possible distinct properties, interactions, and effects that may differ from conventional forms of the same materials.


The European Medicines Agency launched a micro-, small- and medium-sized-enterprise (SME) office in 2005. The office is dedicated to addressing the particular needs of smaller companies.

The SME office aims at promoting innovation and the development of new medicines for human and veterinary use by SMEs by providing information and assistance on Incentives,How to apply, SME register, Workshops, Guidance.

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