Before a medicinal product can be placed on the market, it must demonstrate quality, efficacy and safety—and be granted a Marketing Authorization (MA) by a Regulatory Agency.
While efforts such as the Common Technical Document provide some guidance and consistency to global application procedures, the route to MA can still vary from country to county. Regulatory Agencies have the power to enforce requirements at a regional level—leading to local idiosyncrasies and unique challenges.
Once a drug receives MA, the license holder is also required to demonstrate CMC compliance and conduct on-going, post-marketing safety surveillance.