Stability Studies of API and Regulatory Requirements For Registration of API in Tanzania, South Korea and India

Abstract

This thesis mainly focuses on the stability studies and regulatory requirements for registration in Tanzania, South Korea, and India. The regulatory bodies for Tanzania, South Korea and India are TMDA (Tanzania Medicines and Medical Devices Authority), MFDS (Ministry of Food and Drug Safety) and CDSCO (Central Drugs Standard Control Organization) respectively. The scientific and commercial success of pharmaceutical drug substance lies in the process of stability studies. To perform Stability Studies, the guidelines revolve around the climatic zones of each country, number of batches to be selected for testing, general specifications, testing frequency, storage conditions, and statements and labelling. To allow the entry of drug substance into the market, regulatory registration is a pathway for the approval of it. Registration requires various documents that confirm quality, safety, and efficacy of the substance. Foremost supporting factor in the growth of the pharmaceutical market will be the urbanization in the country and increasing population of the nation. Each country has specific requirements for procedures that vary from nation to nation. This often becomes tedious and time consuming for the manufacturer and the exporter. Thus, this comparative study will be helpful for better understanding of the registration pathway, documents required, administrative and general requirements, and regulatory filing procedures.