Electronic submission offers benefits for pharma, says ISI
Drug firms continue to make basic errors in their electronic submissions according to French regulatory group the AFSSAPS, which said recently that it returns half the NeeS dossiers it receives as they do not meet basic validation standards.
Speaking to Outsourcing-Pharma at DIA EuroMeeting in Monaco Kate Wilber, director of European regulatory services at Image Solutions (ISI), said that while electronic submission can save time and money, there are hurdles to be overcome.
Wilber explained that regional variations, difficulties in translating English eCTD documents into other languages and the complexity of European non-eCTD electronic submissions (NeeS) can cause problems.
She added that rejection of improperly formatted electronic submissions can generate a considerable amount of bad press before reviewers have even had the chance to examine the data contained within.