This topic aims to explain and compare the different regulations and processes for approval of drugs in regulated and non
regulated market. The pharmaceutical industry is one of the highly regulated industries, to protect the health and well being
of the masses. The overall objective of a stringent drug approval system is to ensure that medicinal products of acceptable quality
and efficacy are manufactured.
By law, all new drugs must first be shown to be safe and effective before they can be approved for marketing. A regulated market
is the provision of services that is regulated by a government approved body. Drug approval standards in regulated countries are
considered by many to be the most demanding in the world. Discovering a new drug, and shepherding it through various review
process, can take many years. To a large degree, these costs are mostly associated with the clinical testing.
C oming to approval of drugs in typical non-regulated markets, they are becoming an important player in drug manufacture, in
particular, the production of generics. Many of the generics produced are now found in all parts of the world.
In conclusion, this study deals with the comparison of drug approval requirements between various regulated and non-regulated
markets that could result in a clear understanding of the market positions of different countries and most importantly revise
regulations for a healthier tomorrow.
V. Sowmya is a student of JSS College of Pharmacy, JSS University, Mysore. She has completed her B.Pharm from JSS College of Pharmacy under
RGUHS, Bangalore, India during 2007-2011. She is presently pursuing M.Pharm in Pharmaceutical Quality Assurance. Her areas of interest are
Quality Management, Drug Regulatory Affairs, GMP Auditing.
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