Regulatory Compliance Management and eCTD Compilation of Generic Transdermal Patche For US Market

Abstract

Simply stated, regulatory compliance means following the rules and standards, which is set by government legislation to protect patient from various health issues. Countries like United States, European Union have started implementing various standards and regulations like ISO 19600 and ICH Guidelines, which help them to achieve targeted quality product with better patient compliance. These highly regulated countries harmonize with other regulatory bodies for imposing their standards to make them regulated. After the establishment of Hatch-Waxman act, generics has come to market and now they have achieve that peak which can make better regulating market. Regulatory compliance management can act as tool to achieve regulatory standards. Earlier industries were focusing on oral drug delivery system but now they moved to other route of delivery like inhalation, topical and many more. Topical drug delivery system act considerably as an emerging generic market after the oral and nasal route of administration. The two categories of drug products are available which are topically administered via skin. The most common drug product applied to the skin are Transdermal Drug Delivery System or Transdermal Patch. Formulation of patch is very challenging part for any industry due to their manufacturing and quality concerns. Nowadays pharma industries are looking forward to establish various approaches like QbD to achieve regulatory standards. Pharma company is required to make positive and significant influence towards regulatory compliance to fetch several lawful consequences.