E-Filing for Drug Approval

AUTHENTICATION The pharmaceutical industry has found a new use for digital signatures. In February, AstraZeneca submitted the first end-to-end electronic drug application to the U.S. Food and Drug Administration.

Much of the clinical trials submission process has been electronic for years, but the documents involvedroutinely reaching past 1 million pieces of paper for one drughad to be signed by everyone who worked on a drug trial and then held in active files while the drug is in use (as long as 50 years).

Electronic filing means that information can be stored for quick referralleading to a faster and cheaper drug application process, proponents argue.

For the digital signatures to be legal, there had to be validation that the transaction occurred, verification that the document had not been tampered with and authentication of the signature of the person who signed the document, according to digital signatures vendor Arcot, which was involved in this transaction.

As we go forward and look at development of new medicine, the cost is climbing. There are huge efficiencies to be made in R&D, particularly in this area. Forty percent of all R&D costs are paper costs, says Mollie Shields-Uehling, president and CEO of the nonprofit SAFE-BioPharma Association, which created a digital signature standard for the drug and healthcare industries.

The transaction requires an online certificate service provider to give updates on the status of the credential at the time of the digital signing.

Margaret Locher