Group Promotes Global Digital Identity Standard

Eight global pharmaceutical companies are the founding members of a not-for-profit limited liability company formed to support widespread adoption of a global identity standard that can simplify business and regulatory interactions.

Called SAFE-BioPharma, LLC (www.safe-biopharma.org), the company will establish and maintain the standards and operating rules for the provisioning and management of digital credentials used in electronic clinical research records between the biopharmaceutical industry and government regulatory agencies globally. The eight founding members are AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, and Sanofi-Aventis. Amgen has also agreed to be a member.

The SAFE digital credential standard was developed to simplify business partner interactions across the biopharmaceutical industry through a policy and technology framework for digital signature and authentication. This allows the SAFE community to eliminate the need for multiple identity credentials when interacting with each other and with business partners.

The SAFE coalition has been working together for more than a year to develop the policies, procedures, and technical specifications that form the SAFE standard. To ensure that the standard meets global regulatory requirements, SAFE-BioPharma has collaborated with the U.S. Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and Pharmaceutical Research and Manufacturers of America (PhRMA).

The initial version of the SAFE standard was completed in June 2004. SAFE sponsors are now implementing the digital credential standard across a wide variety of applications to securely authenticate business partners to review, edit, and digitally sign business documents. SAFE-BioPharma is expected to be in operation by March 2005.

"As an industry, we can now simplify our business partner interactions and increase our electronic submissions to the regulatory agencies globally,” commented Gary Secrest, director of World Wide Information Security at Johnson & Johnson (New Brunswick, NJ, USA). "SAFE-BioPharma provides reduced costs through a shared cost model, and sponsors benefit from the shared experience of developing and implementing the standard.”





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