AstraZeneca is First to Use SAFE™ Digital Signatures for FDA Submissions

FORT LEE, N.J. - An in-depth white paper is now available describing how AstraZeneca, using SAFE™ digital signatures, became the first pharmaceutical company to submit its required drug-reporting documents electronically to the U.S. Food and Drug Administration through the Agency’s Electronic Submissions Gateway. In doing so, AstraZeneca reached a milestone in its goal of eliminating the overhead to create, sign, store, and maintain paper originals.

The company submitted its first electronic original form to the FDA in September 2006. Since then it has successfully submitted more than 150 drug-safety and other digitally signed documents to the FDA (these include 2252, 356h, 1571, eCTD).

The white paper, “AstraZeneca Implementation of SAFE Digital Signatures,” is available, free, from the SAFE-BioPharma Association website. SAFE-BioPharma Association is the non-profit association that developed and manages the SAFE digital identity and digital signature standard.

Additional information about pharmaceutical industry use of SAFE digital signatures and their acceptance by the FDA will be presented at two upcoming Drug Information Association (DIA) conferences.

“SAFE Digital Signatures and Identity Management” will take place Thursday, May 24, in Philadelphia. The one-day conference will feature speakers from the Food and Drug Administration, AstraZeneca, GlaxoSmithKline, Pfizer, Johnson & Johnson, and Procter & Gamble, and demonstrations by Arcot, Adobe, Microsoft and Gemini Security Inc./Cardinal Solutions Group. For more information, visit www.safe-biopharma.org.
“Current Advances in eSubmissions: How Digital Signatures are Transforming Information Exchange” will take place Thursday, June 21, as part of the Annual Meeting of the DIA in Atlanta. The morning session will feature speakers from SAFE-BioPharma Association, the FDA, GlaxoSmithKline and Procter & Gamble. For more information, visit www.diahome.org.