BRIEF—Electronic submissions of pharma dossiers in EAEU & ICH region

Last month in Moscow, Russia, the Regulatory Workshop was organized by Eurasian Economic Commission.

Taking part were the pharma trade groups AIPM (Russia’s Association of International Pharmaceutical Manufacturers) and the European Federation of Pharmaceutical Industries and Associations ( EFPIA) with participation (F2F & VC format) of regulatory authorities of the Eurasian Economic Union (EAEU) member-states, European Union regulators, IT specialists and industry to discuss regulatory aspects, practical implementation issues and road map of eCTD implementation in ICH region & electronic submissions in the EAEU region.

Submission of the dossier in the electronic format became an important part of the 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 on the following links:

link 1

link 2

link 3