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REGULATORY REQUIREMENTS FOR GENERIC AND NEW DRUGS REGISTRATION IN RUSSIA
Vallepu Aswani*, S. Sri Lakshmi Nikhitha, T. Sai Kishore, Brahmaiah Bonthagarala, Y. Ratna Sindhu, G. Ramakrishna and M. V. Nagabhushanam
ABSTRACT Biological products or biopharmaceuticals are medicinal products derived from living organism systems and manufactured by using modern biotechnology that differ widely from the conventional synthetic drugs. According to some estimates, Russia is poised to be among the top five global pharmaceutical Markets in terms of value in the next couple of years. Due to the impetus shown by the government regarding the evolution of the Russian regulatory framework for pharmaceutical products, this and other market trends suggest that Russia will soon become a powerhouse destination for pharmaceutical manufacturers and contract research organizations. Keywords: Russia, Roszdravnadzor, Regulatory Requirements, Registration Process. [Download Article] [Download Certifiate] |