An Overview of Regulatory Requirements For API and FDF In Brazil, Vietnama and CIS Countries

Abstract

Medicine is an integral part of mankind. It can be defined as a substance which helps in prevention and treatment of a disease. But before making a drug product it has to undergo years of research and clinical trials to determine its safety and efficacy. Regulatory requirements is an important pathway for a drug to be approved and enter into the market. Brazil is the largest country of South America. “The Health Surveillance Agency of Brazil (Agencia Nacional de Vigilancia Sanitaria – ANVISA) was created in 1999 with the primary aim to promote and protect public health over the products and services in Brazil.” In India the CIS part has huge growth prospective. This part “includes 12 countries as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova.” There are distinct regulatory requirements for the registration of pharmaceutical product for the identical region which has become a stretching job for the manufacturer and exporter. The Regulatory authority of Vietnam is Drug Administration of Vietnam (DAV). The rapidly emerging economic sector and increasing demands for quality healthcare presents Vietnam as a beneficial market for foreign Drug manufacturers.