Current Framework, Ethical Consideration and Future Challenges of Regulatory Approach for Nano‐Based Products

• Published in: Nanopharmaceutical Advanced Delivery Systems pp. 447 - 472
• Main Authors: Dave, Vivek, Sur, Srija, Gupta, Nikita
• Format: Book Chapter
• Language: English
• Published: Hoboken, NJ, USA John Wiley & Sons, Inc 12.01.2021
• Subjects: Australia; European Union; global governance; nanopharmaceutical product; Regulatory; United Kingdom; United States
• ISBN: 9781119711667; 1119711665
• DOI: 10.1002/9781119711698.ch19

There is a great demand of maintenance of regulation of nano drug delivery systems in the aspect of ethical, legal and social impact. This led into the establishment of regulatory agencies which can be governmental, non‐governmantal, hybrid or may be self‐regulated. Drug delivery systems of good quality, safety and efficacy can be introduced into the market so, as to prevent, protect and conserve public health and his environment. For regulation and monitoring of nano products, various countries have adopted proper channels of regulatory measures to accomplish the aim. These have ensured to express the regulatory guidelines of the regulatory agencies at a global level. A proper regulatory setup helps in aiding up in the estimation of global governance gap and solution related to that of pharmaceutical nanomedicine. Countries like United States (US), United Kingdom (UK), European Union (EU), Australia, play great role in the establishment and regulating policies and guidelines. The various guidelines followed by the various countries have also been described in brief in the chapter. The chapter summarizes all the challenges as well as the future prospect of these regulations that are to be followed for the complete end‐to‐end development of the nanopharmaceutical product. It expresses various advantages and disadvantages involved in the monitoring of the pharmaceutical drug delivery systems. Last but not the least, it gives idea about many countries which have already initiated establishment regulatory agencies and implementation of rules and policies with a motive for safe as well as effective regulation of nanoproducts and also helps ourselves to prepare for the future.