Over the past 18 months the European Medicines Agency (EMA) has kick-started its electronic submissions project. The eSubmission Gateway went live in April 2012, and now the EMA is set to roll out the next phase of the initiative--digital signatures.
EMA will accept digital signatures on electronic documents for scientific advice, orphan drugs and pediatric submissions from next month as part of a phased introduction of the technology, PMLiVE reports. Over time the EMA will accept digital signatures on more submissions, with a view to eventually moving to a wholly-electronic model. In a Q&A document, the EMA said the use of digital signatures is 'not yet mandatory.'
The phased introduction will give biopharma time to adapt. Until now companies sending files to the EMA had to sign and scan a paper document or deliver a hard copy by mail. Ending the need to perform either of these tasks should save companies a little time and money, but they must first adopt digital signature technologies. The EMA advises companies to talk to their IT departments from the outset, but the process sounds straightforward. The agency will send certified electronic application forms companies can sign using a PDF reader application.
The EMA believes its acceptance of digital signatures will make the secure archiving of legally binding electronic documents more efficient. The move continues the EMA's shift toward electronic documents that gained momentum last year when the eSubmission Gateway went live. EMA accepted electronic filings in parallel with paper submissions for almost a decade before rolling out the eSubmission Gateway, but the complexity of the process limited uptake.