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Need for harmonization in regulatory testing of nanomedicines

Need for harmonization in regulatory testing of nanomedicines
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JRC scientists, in close collaboration with Norwegian SINTEF Institute for Materials and Chemistry, have conducted a survey among regulatory scientists of nine international competent authorities with the aim to obtain a general overview on the current status and regulatory needs of nanomedicines.

The outcome elucidated strong regional differences on the number of nanomedicines seeking for clinical trial approval or market authorisation and confirmed the need to harmonise information requirements and standardised methods addressing nanospecific properties of the product.

Nanomedicines are an emerging product class in the health sector and need to comply with the high standards of the medicinal product regulation or other related legislative frameworks. However, robust datasets defining nanospecific properties that can have an impact on quality and safety requirements are usually not available due to the innovative character of nanomedicines and the diversity of this product class.

Such a lack of firm conclusion on the information requirements and standardised methods in the regulatory process can contribute to uncertainties for product developer and regulators and delay the availability of nanomedicines for the patient.

In 2015, the European Nanomedicine Characterization Laboratory (EU-NCL) was set up as starting community by the European H2020 program with a similar goal as the US Nanotechnology Characterization Laboratory of the National Cancer Institute (NCI-NCL).

In order to ensure that methods developed/validated by the EU-NCL are relevant for regulatory purposes and the obtained information can support the regulatory decision making, the JRC and its partner carried out a series of questionnaires addressing different groups of regulatory scientists.

The International Pharmaceutical Regulators Forum carried out this survey within their nanomedicine working group. It gives a worldwide overview of the experience of authorities with nano-enabled health products.

There are significant regional differences in the number of nanomedicines that look for clinical trial approval or market authorisation.

This calls for a close collaboration between authorities in order to:

  • develop and standardise appropriate test methods for nano-specific properties within the Nanomedicine community
  • raise awareness on particular requirements when developing borderline/ combination products or nano-similars

Read more in: S. Bremer-Hoffmann al.: Identification of regulatory needs for nanomedicines , Journal of Interdisciplinary Nanomedine 3 (2018) 4-14 ISSN 2058-3273,doi: 10.1002/jin2.34

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2018 m. liepos 10 d.