Suchergebnisse

Common Technical Document (CTD) 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 put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authorization of the generic medicinal product in Europe, the applicant should submit abridged application to the relevant authority. The ability to accommodate country specific requirements and understand regulatory differences will have a substantial impact on the success of its multi country submissions strategy. Generic manufacturers must file an Abbreviated New Drug Submission (ANDS), and the CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approval procedures. Keywords: CTD, Generic drug, CDSCO, Bioequivalence, ANDS.

Common Technical Document (CTD) 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 put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authorization of the generic medicinal product in Europe, the applicant should submit abridged application to the relevant authority. The ability to accommodate country specific requirements and understand regulatory differences will have a substantial impact on the success of its multi country submissions strategy. Generic manufacturers must file an Abbreviated New Drug Submission (ANDS), and the CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approval procedures. Keywords: CTD, Generic drug, CDSCO, Bioequivalence, ANDS