for the conventional drug therapeutics. The usage of prevailing guidelines and

standards to regulate nanotechnology-enabled therapeutics has been fraught with

numerous difficulties. Afterwards, the nanotechnology-enabled therapeutics started

flooding in the marketplace, the US-FDA in 2006 started to determine and develop

regulatory methods that aid in the continuous development of advanced, effective

and safe FDA-managed drug products, made out of nanoscale materials (Nanda et al.

2015). In 2011, the European Medicines Agency (EMA) published on the necessity

of regulatory requirements on nanomedicines for their approval, related to key issues

associated with their development, characterization and challenges with the chemis-

try, manufacturing as well as regulation of the nanotechnology-based therapeutics

(European Medicines Agency 2014a, b). Subsequently, the EMA came up with the

guidance for the pharmaceutical manufacturing sector on the genuine provisions for

liposomal products in 2014 (European Medicines Agency 2014a), surface modifica-

tion on nanomedicines in 2013 (European Medicines Agency 2013), development of

block-copolymer-micellar drug products in 2014 (European Medicines Agency

2014b) and colloidal intravenous iron nanoparticles in 2015 (European Medicines

Agency 2015). Quite lately, in December 2017, the US-FDA provided a draft

guidance for industries associated with nanotechnology-based applications on

“Drug Products, Including Biological Products, That Contain Nanomaterials”

(FDA 2017; Department of Biotechnology Indian Society of Nanomedicine 2019).

In fact, the FDA does not unequivocally denounce all the nanotech-enabled thera-

peutics as fundamentally benign or toxic. Besides the US-FDA guidance on

liposomal drug product, the regulatory agencies of Canada, Australia, Taiwan,

India and Japan have also issued their identical guidance for managing the

applications pertaining to intravenous liposomal preparations (Ministry of Health

Labour and Welfare Japan 2016; Therapeutic Goods Administration Australia 2016;

Centre for Drug Evaluation Taiwan 2017; Health Canada 2017; Department of

Biotechnology Indian Society of Nanomedicine 2019). Figure 18.13 outlines an

overview of varied federal agencies involved in the regulation of nanomedicines.

Implementation of systematic as well as rational principles of QbD into the

preparation of nanoparticulates, to a great extent, has been appreciably valued across

the pharma world for varied aspects of pharmaceutical drug products, processes and

drug substance manufacturing too (ICH Harmonised Tripartite Guideline 2005,

2008, 2009). Nonetheless, hardly any guidance(s) specific to the applicability of

QbD/FbD approaches in the preparation of nanotech-based therapeutics has been

issued yet. A distinct number of formulations as well as process factors have now

been identified that could impact the CQAs like nanoparticle size, drug loading, drug

release behaviour and biopharmaceutical attributes (De Crozals et al. 2016; Khurana

et al. 2017; Li et al. 2017; Singh et al. 2018a, b). Accessibility of pharmaceutical

product-related guidance on QbD-steered development of drug nanopharmaceuticals

is, nevertheless, highly coveted, not only to control and assure the quality, safety,

efficacy and robustness of these multifaceted pharmaceuticals, but also to support

and motivate diverse pharmaceutical companies to produce safer and more thera-

peutically effective nanostructured systems for addressing the patients’ unmet needs.

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