Title:Development of Nanomedicines and Nano-Similars: Recent Advances in Regulatory Landscape
Volume: 28
Issue: 2
Author(s): Rishi Paliwal*, Pramod Kumar*, Akash Chaurasiya, Rameshroo Kenwat, Sumeet Katke and Shivani R. Paliwal
Affiliation:
- Nanomedicine and Bioengineering Research Laboratory, Department of Pharmacy, Indira Gandhi National Tribal University, Amarkantak, MP,India
- Helmholtz Zentrum München, Ingolstädter Landstraβe 1, D-85764 Neuherberg, Germany and Comprehensive Pneumology Center, Max-Lebsche-Platz 31, 81377 Munich,Germany
Keywords:
Nanomedicine, nanosimilars, nanotheranostics, regulatory, pharmaceuticals, nanodevices, drug delivery.
Abstract:
Background: Nanopharmaceuticals serve as emerging forms of modern medicines, which include
nanomedicines, nanosimilars, nanotheranostics, nanodevices, and many more. In the last two decades, a large
number of nano-based products have reached the market and are being used clinically.
Objectives: Unlike conventional pharmaceutical products, nanopharmaceuticals behave differently both in vitro
and in vivo, and therefore, the development of their generic versions needs special attention to replicate the similar
drug release pattern leading to an identical therapeutic outcome. Further, drug-device combinations and 3D
products are the latest advancements in precision medicine delivery and development.
Methods: The regulatory guidelines for these products are being framed at many stages by various regulatory
agencies like USFDA/EMA and still are in infancy at the moment if we look at wider perspectives and applications
of nanomedicine.
Results: For a formulation scientist, it is much needed that well-explained and directive guidelines should be
made available before leading to the development of the generic versions of these nano-cargos.
Conclusion: Here, in this review, we have summarized the silent features of the regulatory perspectives related
to nanotechnology based next generation therapeutics and diagnostics.
