Metrology for innovative nanotherapeutics
Nanotherapeutics: In MetrINo we consider nanotherapeutics both: (i) pharmaceutical products classified as nanomedicines (EU) or nano-enabled drug products (USA) and (ii) nano-enabled medical devices, containing nanoparticles as defined in this glossary. The definition of nanomaterial may vary according to the classification and to the associated regulation.
Medicinal product: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
[SOURCE: Directive 2001/83/EC]
Medical device: any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: — devices for the control or support of conception; — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) of the EC directive 2011/696/EU and of those referred to in the first paragraph of this point.
Note 1 to entry: For medical devices, the definition of nanomaterial of the EC directive 2011/696/EU and its revisions apply.
[SOURCE: Medical Device Regulation (EU) 2017/745]
Nanomedicine: Currently a formal definition of nanomedicines does not exist. The European medical agency (EMA) has established a working definition for nanomedicines, based on following considerations: (i)Purposely designed systems for clinical applications; (ii) At least one component at nano-scale size that should not exceed 1000 nm; (iii) resulting in definable specific properties and characteristics
Note 1 to entry: For pharmaceutical products, both EMA and the US Food and Drug Administration (FDA) consider an extended definition of nano-materials, including sizes not exceed 1000 nm.
[SOURCE: The REFINE white paper]