1Department of Pharmaceutical Quality Assurance, Faculty of Pharmacy, Parul Institute of Pharmacy and Research, Parul University, Post Limda, Waghodia, Vadodara, Gujarat, India
2Associate Professor and HOD Pharmaceutical Chemistry DepartmentParul Institute of Pharmacy and Research, Parul University, Post Limda, Waghodia, 391760, Vadodara, Gujarat, India
*Corresponding author
Online published on 15 November, 2022.
BRICS are economically incorporated the developing markets of Brazil, Russia, India, China, and South Africa. In, the Pharmaceutical market rapidly increasing growth in the administration framework of Medication and Administrative Medication Law. The main objective of this study is to compare the Registration and Approval process in different Countries for Generic Drugs. The Registration process in India and China are different. Even, though Brazil, Russia, and South Africa also follow CTD format in Module I for Requirement of registration. All countries include the highest world pharmaceutical economy in the world to create a significant opportunity for pharmaceutical companies by direct foreign investment and showing growth. They have the largest entity on the global stage of the world. The main goal of this study is to the comparison of generic medication of drug registration process in BRICS countries, in, that Russia and Brazil have different approval processes so that the newer technologies we have found in the countries. India, South Africa, and China have CTD format requirements so, that this Module-1 is very different. More rising largest globally emerging BRICS markets are having significant or beneficially Opportunities. According to different guidelines, we are opinion to and that regulation is carrying out. In, Brazil is having good, human service and current medication it is economically good for the developing market in global prospect. ICH prefers that the anniversary of preparing a dossier for Safety, Quality, and Security of API and Product Specification. So, that in this review we have discussed the above Registration and Approval Process BRICS countries.
Regulatory Requirement, BRICS, Generic Products, CTD, GMP, CDSCO, DCGI, API, CFDA, SFDA, ICH