Ananya Parashar, Arti R. Thakkar
ABSTRACT
This review aims to compare the pharmaceutical regulations of developed nations such as Singapore, Australia, Canada, and Europe. The present work describes the need of pharmaceutical regulations and how these Regulations have evolved with time. Regulatory bodies of different countries play a huge role in the type of procedures, methodologies,
and guidelines adopted by each nation. The comparison gives an insight into the different clinical trial pathways, drug registration procedure, CTD format, medical device registration, and consultation provisions offered by the following nations. Countries of interest chosen here are based on demographic parameters, population, and regulatory body establishment. These nations have a strong regulatory system that sets an example for the emerging pharmaceutical market. They account for a large number of populations ranging from 26 million in Australia, 38 million in Canada, and
738 million in Europe. Singapore is a small nation with a population of 5.8 million people. However, it has emerged to be one of the leading potential markets in the pharmaceutical industry.
Key words: Clinical Trial Application, Clinical Trial Notification, Health Sciences Authority, Therapeutic Goods Administration, Health Canada, European Medicines Agency