Electronic Common Technical Document (ECTD) Filing in Europe and Comparative Study of Dossier Requirements for Generics Across US, Europe, Australia and New Zealand

Abstract

Electronic submissions as a part of global perspective act as a efficient interface between industry and regulators which enhance navigation, integrity and lifecycle management. The eCTD standard describes a message format and protocol for transferring submission documents and processing instructions to an agency system. XML backbone is an important feature of eCTD which manages metadata in submission and offer subsequent ease in navigation. eCTD is mandatory for US and Europe but still NeeS is accepted for some application types. Harmonization is greatly achieved among the MSs of Europe, as almost all the NCAs have adopted the eCTD standard for submissions. Australia has initiated implementation of eCTD from 2015 and New Zealand, eCTD is yet not implemented. This thesis deals with comparative study of dossier requirements concerning registration of generics across US, Europe, Australia and New Zealand. It is important for generic companies, to cautiously evaluate the market interest, cost, feasibility and regulatory requirements before the registration of medicinal products. In terms of diversity and population with varied procedure Europe is a favorable market for authorization. Present thesis elaborated eCTD submission processes of European nations and module wise comparison between US, Australia and New Zealand.