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ABSTRACT
Generic drug registration is a very strenuous and complicated process in many countries. It varies from country to country based on their regulations. Due to various regulations, the ICH came into picture introducing ‘CTD’ (common technical document) for countries which come under it. Common Technical Document provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant differences in the dossier submission requirements in these countries. This study deals with the differences in registration requirements for generics in European Union, United States and Brazil. Generic drugs in EU are approved under the Marketing Authorization Application and in US they are approved under the Abbreviated New Drug Application, whereas in Brazil it is under the filing of provincial FDA. Bioavailability and Bioequivalence study data is critical in the generic drug approval process as clinical trials can be omitted. This study also deals with the few comparisons of generic drug registration requirements in these three countries. Understanding the differences in registration process will have a substantial impact on the success of its multicounty submissions strategy. generic drug (shortly: generics) is a drug defined as “a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.” It has also been defined as a term referring to any drug marketed under its chemical name without advertising. Generic drugs are therapeutically equivalent to a branded drug Therefore; the appropriate submission strategy in advance could make a smooth review process without any significant delays or failures.

Keywords: ICH, CTD, Dossier, Registration requirement.

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