Regulatory framework on nanotechnology products: how to strike a balance between innovation and public health

The growing application of nanomaterials in healthcare products (i.e., cosmetics, medical devices, and medicinal products) has encouraged the upgrade of the regulatory framework within the European Community to better control their use and manage the risk of negative effects on human health and environment. Unfortunately, despite the efforts of European Authorities, several criticisms remain on the ground, due to the no well-established scientific knowledge on nanomaterials. The regulatory umbrella designed by European Commission is deliberately universal and, therefore, is not able to fix all criticisms on the ground. While the regulatory framework for the cosmetic products is almost consolidated, the efficacy/safety assessment of nanomaterials in medicinal products and medical devices is still based on case-by-case evaluation due to the high complexity of such systems. For pharmaceutical applications, the term “nanomedicines” (or “nanomedicine products”) is generally used, from a scientific point of view, to identify medicinal products issued by a nanotechnology in their design or production. Consequently, the development, the manufacturing, and the marketing of nanomedicines fall under the provisions of the existing regulatory frameworks on medicinal products. In this light, the benefit/risk balance of nanosystems is performed by regulatory authorities based on the quality attributes that may impact on efficacy and safety patterns. Although the existence of some nanosystem-specific guidance released by Regulatory Authorities (e.g., EMA, FDA), the need to develop methodologies and protocols specifically validated for assessing in vitro the performance of nanomedicine products remain on the ground.