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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Comparitive study of generic drug registration process in EU, USA & China


2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Gowtham Vajjhala

Posters: Pharmaceut Reg Affairs

Abstract :

Generic drug approval is a very strenuous and complicated process in 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 in this study the countries which belong to ICH are US and Europe. 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.

Biography :

Gowtham Vajjhala has completed his B.Pharm in JSS College of pharmacy, Mysore and currently pursuing II M.Pharm ? Pharmaceutical Quality Assurance in the same College (i.e.) JSS College of Pharmacy, Mysore, Karnataka. He has given many seminars and poster presentations in National and International level Symposiums.

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