Acceptance of digital signatures is in line with EMA’s strategy for a “future electronic only workflow” between itself and the pharmaceutical industry by eliminating the need and cost associated with printing, sending and archiving paper documents. Electronic only workflows involving regulatory submissions will require use of E.U.-qualified digital signatures such as those based on the SAFE-BioPharma standard.
The agency is starting with digital signature-enabled PDF forms for scientific advice, orphan medicines, and pediatric submissions.
In a related announcement underscoring the agency’s strategy to increase electronic-document-only exchanges with industry, EMA said it “will start to use digital signatures systematically in outgoing documents that currently require a legally binding signature.”
“EMA’s acceptance and use of digital signatures sends an important message to biopharmaceutical companies, many of which have digital signing capability as part of their existing use of SAFE-BioPharma digital identity credentials,” said Mollie Shields Uehling, president and chief executive officer, SAFE-BioPharma Association.
The SAFE-BioPharma standard was established by the pharmaceutical industry with the participation of the EMA and FDA to create and maintain an interoperable digital identity and signature standard that allows secure, trusted exchanges and legally-binding digital signatures. SAFE-BioPharma member companies have conducted several pilots with the EMA demonstrating that the SAFE-BioPharma standard meets E.U. electronic signature requirements and that the EMA can recognize and validate SAFE-BioPharma compliant signatures.
The E.U. definition of digital signatures is consistent with SAFE-BioPharma digital signatures. Specifically, each signature is:
uniquely linked to the signatory
capable of identifying the signatory
created using data that the signatory can use under his/her sole control with a high level of confidence
linked to the signed document in such a way that subsequent change in the document is detectable.
The EMA requires digital signatures on submissions be issued from Certification Authorities (CAs) under the authority of the national agencies on the E.U. trusted list.
