Regulatory Aspects of Oncologicals: Nanosystems Main Challenges

Regulatory aspects on nanomedicines

“…As a consequence, the regulatory environment for those innovative nanomedicines has been increasingly challenged by key issues, which is an opportunity to provide clearer guidance for their development [14].…”

“…Nowadays, regarding nanomedicines in the market, circa 40% of them are based on protein-polymer conjugates and liposomal formulations [14]. The treatment of tumor diseases is one of the major principal therapeutic targets for these nanomedicines.…”

“…The first FDA-approved nanomedicine was Doxil®, a doxorubicin-loaded PEGylated liposomal formulation for cancer treatment. After 20 years from its approval, this nanomedicine continue to be extensively used and constitutes the pattern of injectable nanodrugs and drug delivery systems [14,18]. Doxil® has been used for the treatment of Kaposi sarcoma in HIV patients, ovarian cancer treatment, metastatic breast cancer and multiple myeloma [11,35].…”

“…Additionally, before commercialization of these nanomedicines, it will be essential to perform pharmacoeconomic studies to demonstrate both social and economic added value of these novel products when compared with established treatments. Important indicators such as increment in QALYs (quality-adjusted life expectancy years) or costs associated to future consecutive hospitalizations shall be considered in the development of these new and sophisticated nanomedicines [14].…”

Nanomedicine to Tumor by Enzymosomes

“…However, considerable progress has been made in the last years, reflecting the recognition by regulatory authorities specific features associated to the nanosystems-based medicines. As a consequence the regulatory environment for those innovative medicinal nanosystems has been increasingly challenged by key issues, which has been an opportunity to provide clear guidance for their development [21].…”