On the edge of new technologies (advanced therapies, nanomedicines)

Nanotherapeutics in the EU: an overview on current state and future directions

“…This is of particular importance, since nanotherapeutics may exhibit a complex mechanism of action combining mechanical, chemical, pharmacological, and immunological properties. 68 Therefore, additional specialized expertise, together with the adaptation of existing methodologies and the development of new methods, may be required for the evaluation of their quality, safety, efficacy, and risk management. 66 For the regulatory decision making, it is imperative to define critical product attributes predictive of product performance in vivo (eg, size specifications, shape, and surface characteristics such as area, chemistry, porosity, and coating).…”

“…66 For the regulatory decision making, it is imperative to define critical product attributes predictive of product performance in vivo (eg, size specifications, shape, and surface characteristics such as area, chemistry, porosity, and coating). [68][69][70] Therefore, both the EMA and the FDA require similar documentation that will prove quality, safety, and efficacy of the nanomedicinal product. Since advances in emerging technologies may be unpredictable and rapid, the FDA also uses a case-by-case approach which is iterative, adaptive, and flexible.…”

“…In addition, nanotherapeutic product quality assurance includes the adequate characterization method validation to control the reproducibility of the critical attributes such as particle size, shape, and surface characteristics including area, chemistry, porosity, and coating parameters. 68 From the EU regulatory perspective, the main challenges refer to applicability and relevance of current methods to assess characterization and biodistribution of emerging nanotherapeutics, particularly related to their in vivo behavior (eg, interactions with biological systems and impact on the immune system). The main concerns are related to the assessment of the comparability with existing nanoformulations, adequacy of tools for risk assessment, classification of converging technologies, adequacy of regulatory frameworks, and regulators' expertise.…”

Regulatory Framework for Nanomedicines

“…The legislative framework for nanotechnological and nanobiotechnological medicinal product approval is constantly changing and developing [14]. Hightechnology nanotechnological product developments even for everyday applications create the need for a legislative framework that will be updated with technological evolutions [2,10].…”

“…This is mainly due to the investment status established in the United States in relation to innovative products and idea promotion, in comparison to the introvert character of the EU countries and Europe in general. Generally there is a need of conductive conversations and good natured effort for the evolution of the present legislative framework for approving new and innovative pharmaceutical products and diagnostics, especially those developed based on nanotechnology [14].…”