The translation of nanomedicines from the lab level into marketed product
faces several challenges, including characterization of physicochemical properties, pharmacodynamics,
pharmacokinetics, process control, biocompatibility, and nanotoxicity,
scaling-up as well as reproducibility. The challenges of nanomedicine development are
in connection with the different requirements from the patient (clinical and therapeutic
use), industry (production), and regulatory bodies (authorization process). This paper
aims at reviewing the status and regulatory aspects of nano-based drug delivery systems
with a focus on the Food and Drug Administration (FDA) and the European Medicine
Agency (EMA) regulations. In addition to discussing the risks accompanied by the development
of nanomedicine, the potential of following a risk-based methodology from the
early stage of the R&D phase is emphasized here to ensure safety and efficacy when developing
novel nano-based dosage forms. The R&D of nanomedicines is a complex and
multidisciplinary approach, and there are still many challenges in their regulation and legislation.
In general, the most critical considerations for nanomedicines are the product
quality assessment (physicochemical characteristics, quality control, manufacturing process)
and product safety assessment (pharmacokinetics, biodegradation, accumulation,
and nanotoxicity). The paper presents a promising paradigm in the development and marketing
authorization of nanomedicines, namely the Quality by Design (QbD) approach.
Sufficient knowledge on the quality, safety, and efficacy of nanomedicines is necessary
to obtain a significant focus on establishing robust, standardized methods for evaluating
the critical quality attributes of nanomedicines. The QbD-based submission is highly recommended
and required by the regulatory authorities, enabling a smooth clinical translation
of the novel nanomedicines.