European regulatory agencies have been busy these last few months. The eCTD Summit has a good roundup of notices and guidances that have been issued across Europe recently.
One thing that stands out is an announcement (translated via Google) by the Bulgarian Drug Agency that all types of procedures must now be in electronic format (eCTD or NeeS).
As of January 1, 2010, eCTDs are mandatory for all centralised procedures. Many national authorities, including the Bulgarian authority, also accept electronic submissions of marketing authorization application dossiers, either as an eCTD or as a NeeS.
Just a couple of years ago, Bulgarian officials sounded a cautionary note [PowerPoint link] regarding electronic submissions. Some of the issues included basic and far-reaching challenges like:
- Delay / lack of communication between the local representative and the head office
- The contact persons for the procedure, based in Bulgaria are not trained to deal with technical issues during e-submissions
- Lack of financial resources and staff of applicant
(Click on thumbnail for larger version; source=02-06_EFPIA_presentation.pdf)
ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.