Abstract
The European Medicines Agency (EMA) regards the potential risks of human medicinal products to the environment and their impacts are assessed, as well as management to limit this impact. Hazard assessment of novel materials, which differ from conventional chemicals, e.g. nanobiomaterials, poses testing challenges and represents a work-in-progress with much focus on the optimization of required methodologies. For this work-in-progress, we here highlight where changes/updates are required in relation to the main elements for international testing based on OECD guidelines, supported by knowledge from the nanotoxicity area. The outline describes two major sections, nanobiomaterials and environmental hazards, including its challenges and learned lessons, with recommendations for implementation in OECD guidelines. Finally, the way forward via a testing strategy is described.
Highlights
The European Medicines Agency (EMA) defines Nanotechnology “as the use of tiny structures—less than 1000 nm across—that are designed to have specific prop‐ erties”: this includes mentioning structures and substances; the structures are designed on purpose and not just happened to be at nanoscale; the structures have specific properties not obtainable in isolation with the individual components of the nanostructure [1]
International environmental hazard guidelines follow a general Organization for Economic Cooperation and Development (OECD) outline and the main elements are selected and discussed (Table 1): We describe where changes are required and why, this supported by individual studies methods and results
There is currently a range of guidelines that were developed for hazard assessment of chemicals, which have been challenged for testing of other materials like nanomaterials (NMs)
Summary
The European Medicines Agency (EMA) defines Nanotechnology “as the use of tiny structures—less than 1000 nm across—that are designed to have specific prop‐ erties”: this includes mentioning structures and substances; the structures are designed on purpose and not just happened to be at nanoscale; the structures have specific properties not obtainable in isolation with the individual components of the nanostructure [1]. There is currently a range of guidelines that were developed for hazard assessment of chemicals, which have been challenged for testing of other materials like nanomaterials (NMs).
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