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Abstract

REGULATORY REQUIREMENTS FOR GENERIC AND NEW DRUG REGISTRATION IN RUSSIA

M. Venkata Sowmya*, J. Sai Bhavana, G. Ramakrishna, M. V. Nagabhushanam, Brahmaiah Bonthagarala and D. Nagarjuna Reddy

ABSTRACT

The purpose of the study was to generic drug registration process in Russia. It can be concluded that the world pharmaceutical economy, the fastest growing and largest emerging markets economies of Brazil, Russia, India, China and South Africa (BRICS) countries are showing positive growth and increasing direct foreign investment by creating significant opportunities for pharmaceutical companies to expand into these markets. They would be the largest entity on the global stage. The drawback in Russia are the regulations are in their local languages and the documents required for registration of drugs should translate into their local languages. It takes time to understand the rules and regulations and for registration. To rectify the differences of the guidelines, we need to go for harmonization. So that we can expect a common guideline worldwide. It will take time to harmonize the guidelines. But once harmonized the guidelines, emerging countries like Russia will get benefit. With ICH formation, the industry foresees harmonization of regulations, so that we can do filing easily. In the interest of industry, we are opinion that all regulations are harmonized and unified regulations are emerged.

Keywords: Regulatory Requirements, Registration Process, Russia, Generic Products.


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