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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 3
First page : ( 1403) Last page : ( 1408)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00234.8

Registration and Regulatory Requirements of Generic Drugs Marketing Authorization in “BRICS” Countries

Jayalakshmi B., Seetharaman R., Kamaraj R.*

Department of Pharmaceutical Regulatory Affairs, SRM Institute of Science and Technology, SRM College of Pharmacy, Kattankulathur-603203 Dist-Kancheepuram, India

*Corresponding Author E-mail: jayaranijini3017@gmail.com

Online published on 18 May, 2019.


The comparative study of generic drug registration in BRICS, was to find out the differences among the guidelines. “BRICS” mainly refers to Brazil, Russia, India, china and South Africa. The regulatory requirements of each country is different from each other, “BRICS” has the fastest growing and largest emerging markets which shows the positive growth in the pharmaceutical companies. The medical regulatory system in the BRICS countries is increasing in the medical profession to safeguard and promote the medicine. The BRICS countries together is consider as important emerging economics, which has 40% of world population. To develop the universal health coverage, The BRICS countries of national institution agreed to join hands with (WHO), world health organization.



Regulatory Requirements, Registration Process, Brazil, Russia, India, China and South Africa (BRICS), Generic Products.


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