Electronic submissions in EAEU & ICH region - current practice & future developments for pharma regulation
19.06.2018On June 18, 2018 in Moscow the Regulatory Workshop was organized by Eurasian Economic Commission and AIPM & EFPIA with participation (F2F & VC format) of regulatory authorities of EAEU member-states, EU regulators, IT specialists and industry to discuss regulatory aspects, practical implementation issues and road map of eCTD implementation in ICH region & electronic submissions in EAEU region.
Submission of the dossier in the electronic format became an important part of review process of medicinal products. The electronic Common Technical Document (eCTD) is the electronic presentation of the CTD. It is a standard format for text, data, and images and facilitates electronic transmission of information from transmitter to receiver. eCTD adoption provides to health authorities and industry many benefits, including paper replacement, better information management, document storage, retrieval, archiving, electronic working, searching, cross referencing, management of product information in the dossier over time, lifecycle support and many others.
Presentations, discussed at the workshop, can be downloaded:
EU experience in eCTD implementation