Abstract
New scientific discoveries and technological applications have been deeply influencing both the R&D and manufacturing of healthcare products, stressing the need for upgrading the regulatory framework, in order to overcome existing regulatory barriers for high-innovation products and to ensure proper quality standards able to preserve public health. In this light, groundbreaking technologies in the pharmaceutical field can be classified as innovation-in-product or innovation-in-process. In the former case, although the existing regulatory pathways can be also applicable to the marketing of high-innovation products, the benefit/risk assessment should be redesigned case-by-case based on the specific features of innovative products. In the latter case, existing technical and regulatory frameworks, which have been designed to meet the need of conventional pharmaceutical production, may not be able to cover all the intrinsic complexity of innovative manufacturing processes (e.g., additive manufacturing). This chapter aims to discuss the critical issues, from a regulatory point of view, in the development of high-innovation products and processes. Nanomedicine products, combination products, and additive manufacturing are reported as case studies of innovative products and processes to highlighting the critical issues in the regulatory pathways for placing them on the market.
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Minghetti, P., Musazzi, U.M., Rocco, P. (2023). Regulatory Aspects and Barriers in Using Groundbreaking Technologies. In: Lamprou, D. (eds) Nano- and Microfabrication Techniques in Drug Delivery . Advanced Clinical Pharmacy - Research, Development and Practical Applications, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-031-26908-0_17
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