Regulatory compliances in development of commercial scale process of Nanoparticles (Liposomes and Niosomes) in pharmaceutical industry : A review

Abstract

The main objective of this review work was designed to explore the regulatory environments that govern the pharmaceutical industry. Main objective of regulatory department is to maintain the quality, safety and efficacy of the medical products it also ensures the standard of medicinal product for sales, importing and manufacturing. The biggest challenge faced by the pharma manufactures is Scaling up their production. Our review process focuses on regulatory requirements concerning Liposomes and Niosomes and their limitations in respect to industrial applicability. In detail explanation of what type of information should be submitted to FDA and EU in new drug applications (NDAs) or abbreviated new drug applications (ANDAs). By comparing these two developed regulatory markets we can build a strong regulation in Indian market on Liposomes and Niosomes. The review study deals with the sound knowledge about regulatory landscape that governs the pharmaceutical industry. Study describes in depth about liposomes and niosomes delivery systems and gives a critical overview of the current regulatory landscape surrounding commercialization efforts of higher-level complexity systems, the expected requirements and the hurdles faced by companies seeking to bring novel liposome and noisome based systems for clinical use to market.