A STUDY ON THE REGULATORY REQUIREMENTS FOR GENERIC DRUG PRODUCTS IN USA, SOUTH AFRICA AND RUSSIA.

Abstract

United States (US) and the EU are the largest and the most potential markets for in the world and are categorized under the regulated markets, while ROW (Rest of the World) market comprise of all the emerging markets like Brazil (LATAM), Africa, Russia (CIS), Hong Kong (ASIA), etc. The regulated market involves those countries where there are defined regulatory requirements fixed by the regulatory bodies of that country and the emerging market countries are those who still are behind in putting forward the well defined regulations for drugs. The regulatory agencies have the authority to control the registration, manufacturing, marketing authorization of the drugs. The regulatory bodies responsible for regulation in US, South Africa and Russia is USFDA, MCC and Roszdravnadzo, respectively. It includes the process of drug regulation and monitoring, and it also includes the process of manufacturing, distribution and promotion. Although the requirements are harmonized in regulated countries by CTD (Common technical document) filing, yet others have massive variety in requirements. It is vital for pharmaceutical industry to grip with the regulatory requirements for betterment of public and to ensure their place in the market. It has been noticed that with the coming years most of the blockbuster drugs will become off patent and this will open the opportunity for other companies to introduce their products inform of generics. This is expected to create market saturation. So a great deal of planning is needed by the companies in the future before introducing their products and also for their survival. This paper approaches the regulatory requirements for registration of pharmaceutical generic products in US, South Africa and Russia. This paper represents a thorough literature review of multiple sources including journal articles and government regulatory websites.