Identification of regulatory needs for nanomedicines

Abstract

The application of nanotechnology in health care is widely accepted as a potential driver of biomedical innovation. By exploiting their unique physicochemical properties, nanomedicines can monitor, repair, and control biological systems in order to address diseases for which currently no or only insufficient diagnostic and therapeutic tools are available. Nevertheless, the opportunities of nanotechnologies in the health sector are accompanied by challenges in the regulation of these products. Sufficient knowledge on their quality, safety, and efficacy must be gained and standardised methods must be made available to support the regulatory decision making and allow a smooth translation towards clinical applications. We have conducted a survey among regulatory authorities with the aim to obtain a general overview on the status and regulatory needs of nanomedicines and to indicate some trends on future requirements. The outcome has demonstrated strong regional differences in the regulation of nanomedicines and confirmed the need for the harmonisation of information requirements on nano‐specific properties. In addition, a number of critical physicochemical properties that have already been proposed in the scientific literature were verified in the survey as relevant for regulatory decision making. Finally, the survey has demonstrated an interest of regulatory agencies in an independent nanomedicine characterisation facility that can support regulators in the evaluation of these systems and at the same time assess the performance of existing and new test methods for their application to the field of nanomedicine.

Main trends of immune effects triggered by nanomedicines in preclinical studies

“…Therefore, many regulators are requesting that validated state-of-the-art in vitro methods containing specific nanosize-related precautions should be developed to assess the immunotoxic profile of NPs for medical use. 100,101 The reflection papers issued by the European Medicines Agency in 2013 related to information needs for IV liposomal products, 102 iron-based products 103 and block copolymer micelle products 104 recommend additional immunotoxicity studies including complement activation and macrophage activation, antigenicity and hypersensitivity reactions using validated in vitro and in vivo methods in sensitive models.…”

Time and cell‐dependent effects of endocytosis inhibitors on the internalization of biomolecule markers and nanomaterials

“…(Koyamatsu et al, ; Zan et al, ) These materials may form a new class of ‘nanomedicines’ delivering and releasing drugs through patient‐ or disease‐related changes at the cellular and subcellular level. (Bremer‐Hoffmann et al, ; Chan et al, ; Khan et al, ) However, in order to convert more of the new carrier systems from the investigational to the clinical phase, much greater understanding of the mechanisms that cells use to process nanomaterials is needed. (Li et al, )…”

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“…20 The application of nanotechnology in health care is widely accepted as a potential driver of biomedical innovation. 16 Nutraceuticals and functional foods have become a multibilliondollar industry worldwide as people realize their potential to improve health with fewer side effects and less expense than commonly used pharmaceuticals and drugs. 40 The term "functional food" sounds more generic, but the history of nutraceuticals/functional foods could be dated back in the late 1960s, for instance, with the findings that polyunsaturated fatty acids could control blood cholesterol level.…”