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European Medicines Agency Now Accepts SAFE-BioPharma, LLC Digital Signatures on eSubmissions


9/5/2013 11:10:53 AM

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FT. LEE, N.J.--(BUSINESS WIRE)--Beginning this month, SAFE-BioPharma digital signatures, widely used throughout the global biopharmaceutical industry, will be accepted by the European Medicines Agency (EMA). Acceptance of SAFE-BioPharma 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 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.

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