Abstract

APPROVAL PROCESS FOR DIABETES DRUGS IN THREE DEVELOPED COUNTRIES

Chaturth Mandora*, Dr. Pranit Shah and John Pappan

ABSTRACT

United States of America is one of the top three countries which has diabetes acquired population. This Disease has a notable population under its influence in Asia, especially in China and India which embraces the countries having the most number of diabetic people. Beyond this, the most shocking and surprising rises of this ailment can be seen in developed countries like Australia and New Zealand which earlier had a no significant record. Invention and Growth of various new healthcare methods, drugs and devices has contributed to some extent towards the control of diabetes, but they have failed knowingly in its complete eradication. The research and development (R&D) department together with digital health are working day and night in the discovery of new drugs, biologics and devices for the cure and control of the disease. Due to the rapid research and new drug inventions, the role and responsibilities of regulatory bodies in the respective counties has increased. Predominantly for the Approval process for the new drugs invented. The Research paper here labels and debates on the different Approval pathways and systems engraved by of The Regulatory Authorities i.e. FDA (Food Drug and Administration) from United States, TGA (Therapeutic Goods Administration) from Australia and MEDSAFE (New Zealand Medicines and Medical Devices Safety Authority) from New Zealand. Here we have tried to ornate the difference in guidance’s, approach towards the disease, statistics on the population influenced and Public awareness amongst the individuals of these three countries. The Methods used in this comparison are analysis of guidelines, case studies, procedures and laws. The papers also compact in short, the type of diabetes and how it is classified. The research paper focus on the three main questions 1. What are the objectives of drug development and approval process? 2. What are the type of applications and approval pathways? 3. How Non-clinical and Clinical trials are conducted? The conclusion of the paper is just an outline comparison of drug approval guidance’s from the official website of the respective federal agencies.

Keywords: Food and Drug Administration (FDA), Therapeutic Goods Administration (TGA), New Zealand Medicines and Medical Devices Safety Authority (Medsafe), Drug Approval Process, Clinical trials.