EMA Now Accepts SAFE-BioPharma Digital Signatures on eSubmissions

<0> SAFE-BioPharma AssociationJon Weisberg, 801-359-9977Mobile: 801-860-9977 </0>

Beginning this month, digital signatures, widely used throughout the global biopharmaceutical industry, will be accepted by the (EMA).

Acceptance of SAFE-BioPharma 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 EU-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 CEO, 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 EMA demonstrating that the SAFE-BioPharma standard meets EU electronic signature requirements and that EMA can recognize and validate SAFE-BioPharma compliant signatures.

The European Union definition of digital signatures is consistent with that of SAFE-BioPharma digital signatures. Specifically, each signature is...

EMA requires that digital signatures on submissions be issued from Certification Authorities (CAs) under the authority of the national agencies on the EU trusted list. TranSped, a SAFE-BioPharma Certification Authority (CA) provider, is included in the EU’s list of trusted CAs, and both TranSped and SAFE-BioPharma CAs are listed under the Romanian Ministry of IT&C list.


EMA Announcement:


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