DRUG APPROVAL PROCEDURE IN EU
Krishna Teja Pharmacy College, Chadalavada Nagar, Renigunta Road, Tirupati - 517501, Andhra Pradesh, India.
K. Praneetha
Krishna Teja Pharmacy College, Chadalavada Nagar, Renigunta Road, Tirupati - 517501, Andhra Pradesh, India.
K. Umasankar
Krishna Teja Pharmacy College, Chadalavada Nagar, Renigunta Road, Tirupati - 517501, Andhra Pradesh, India.
M. Alagusundaram
Krishna Teja Pharmacy College, Chadalavada Nagar, Renigunta Road, Tirupati - 517501, Andhra Pradesh, India.
P. Jayachandra Reddy
Krishna Teja Pharmacy College, Chadalavada Nagar, Renigunta Road, Tirupati - 517501, Andhra Pradesh, India.
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 put forth the differences in registration requirements for generics in European Union and United States. It also gives an overview of the administrative documents required for generic drug registration in Association of South East Asian Nations (ASEAN) CTD i.e. ACTD, Eastern European, Common wealth Independent States, and Latin American countries which follow the CTD format. Generic drugs in EU are approved under the Marketing Authorization Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. There are several approaches to assess BA/BE, each regulatory authority has put forth its own regulations/guidance for conducting BA/BE studies required for approval of generic products. This study also emphasizes on the BA/BE concepts, study conditions, designs and methodology in conducting these studies in EU. 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. Therefore, the appropriate submission strategy in advance could make a smooth review process without any significant delays or failures
4 , 4 , 2014
173 - 189
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