Exalon: Finnish Medicines Agency reports high percentage of electronic submissions received in the first year

The Finnish Medicines Agency (FIMEA) reports that the acceptance of electronic drug regulatory submissions in Finland has been widely embraced by applicants. Although FIMEA does accept drug regulatory dossiers in electronic format only for about 1 year, more than 80 percent of drug regulatory submissions submitted in the first half of 2011 were provided in electronic format.


However, FIMEA has concerns regarding the high number of NeeS dossiers received, as the NeeS format provides significant disadvantages compared to eCTD. According to the FIMEA, applications in NeeS format "are frequently low in quality, highly resource intensive and problematic in terms of future life-cycle management".

Of particular concern is also the fact that fresh NeeS applications continue to be submitted, event though the usage of eCTD format is highly preferred by the agency.

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