The European Medicines Agency (EMA) will next month start to accept digitally signed documents for the first time.
In a phased introduction, the regulator will begin with documents related to scientific advice for human medicines, to orphan medicines and to paediatric-medicine procedures.
The initiative is part of the EMA’s strategy to increase electronic document-only exchanges between the Agency and the pharmaceutical industry.
The EMA’s strategy is to eventually move to an electronic-only workflow, but said the use of digital signatures is “not yet mandatory”.
The EMA’s ‘eSignature’ capabilities allow it to send digitally signed electronic documents (in PDF) and verify digital signatures embedded in such documents.
The changes will allow the EMA to securely archive legally binding digitally signed documents, and it expects to see efficiencies in its filing procedures as a result.
The industry too may benefit, with the EMA noting pharma companies may see cost savings from not having to print documents or courier them to the regulator.
The EMA will provide specific PDF certified electronic application forms to enable pharma companies to digitally sign and submit using a PDF reader application.
The regulator will accept digitally signed electronic documents, and send its own out, through the EudraLink or, where the contents do not require confidentiality protection, by email.
• FAQ: EMA eSignature capabilities
