Title : Navigating the regulatory landscape for nanotechnology-based pharmaceuticals: challenges and strategies for harmonization
Abstract:
Nanotechnology has revolutionized pharmaceutical and biomedical applications, offering a plethora of opportunities in drug delivery, medical imaging, and cancer therapy. However, the unique properties of nanomaterials present significant regulatory challenges that must be addressed to ensure patient safety and facilitate innovation. This presentation will examine the current regulatory landscape for nanotechnology-based pharmaceuticals, highlighting the gaps between existing frameworks and the rapidly evolving field of nanomedicine. I will discuss key regulatory issues, including the classification of "borderline products," the development of Critical Quality Attributes for nanomedicine manufacturing, challenges in establishing consistent safety assessment protocols, and the need for nanomedicine-specific regulatory guidance and expertise. Furthermore, I will explore strategies for addressing these challenges, such as strengthening collaboration between regulatory bodies and research communities, developing trans-sectoral approaches for harmonized regulation, implementing the "one substance, one assessment" initiative, and establishing specialized regulatory laboratories and technical standards for nanomedicines. By addressing these crucial aspects, I aim to contribute to the ongoing dialogue on creating a more effective and harmonized regulatory framework for nanotechnology-based pharmaceuticals, ultimately fostering innovation while safeguarding public health.
