Abstract

COMPARATIVE STUDY OF GENERIC DRUG APPROVAL PROCESS IN EU, USA AND CHINA- A REVIEW

P. Sindhuja*, Pooja Rajan, M. V. Nagabhushanam, Brahmaiah Bonthagarala, D. Nagarjuna Reddy, G. Ramakrishna

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 China. 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 China 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. Therefore, the appropriate submission strategy in advance could make a smooth review process without any significant delays or failures.

Keywords: ICH, CTD, Dossier, Registration.