Global Regulatory

U.S. Food and Drug Administration

The Food and Drug Administration has a goal of creating a total electronic environment, and SAFE-BioPharma is helping.

Every day, SAFE-BioPharma Association member companies digitally sign submissions made to the FDA’s Electronic Submissions Gateway. Use of SAFE-BioPharma signatures for this purpose started in September 2006. To help prepare for this time-saving and efficient use of SAFE-BioPharma signatures, the association developed an Inspection Training program and Inspection Techniques Manual for use by both member auditors and FDA inspectors.

Although the FDA does not endorse any particular electronic signature solution, the agency has written:

The Agency has...worked with the biopharmaceutical community over the past two and one-half years to help ensure that the Signatures and Authentication for Everyone (SAFE-BioPharma) Standard: 1) complies with appropriate guidance, especially as related to 21CFR11; and (2) when used as the basis for implementation of a digital signature capability, the SAFE-BioPharma standard facilitates user compliance with 21CFR11.

With the goal of demonstrating benefits and other features of digital signature technology, SAFE-BioPharma has worked with FDA staff and commercial vendors to develop pilot programs using digital signatures. We anticipate ongoing participation with the Agency to help achieve a total electronic environment.

European Medicines Agency

SAFE-BioPharma digital signatures are consistent with EMA requirements for digital signatures.

EMA is transitioning its requirements to electronic-only submissions. Effective January 1, 2009, EMA strongly recommends electronic-only submissions, either in eCTD or non-eCTD format (eCTD is the recommended electronic format). The agency has made it clear that paper is now an exception to the general e-format recommended for any new and existing application and for all submission types. Rapporteurs and CHMP members no longer receive paper copies.

Effective July 1, 2009, EMA will strongly recommend eCTD-format electronic-only submissions.

The SAFE-BioPharma EU Advisory Council, made up of representatives of SAFE-BioPharma members and other interested parties, works with EMA, EFPIA and EU Member State National Competent Authorities to familiarize EU parties with the SAFE-BioPharma standard and to contribute to the development of regulatory guidance and rules driving the use of digital identities and digital signatures.