Mandate Requires Electronic Submission of Drug Master Files Using Trusted Digital Certificates
Time is running short, and the rush is on for organizations that transact with the FDA to get trusted digital certificates for all individuals working on their behalf. Starting May 5th, the FDA will require all drug master file submissions to be in Electronic Common Technical Document (eCTD) format to bring consistency and efficiency to the drug review and approval process. In addition, eCTD-based communications between life sciences organizations and the agency will have to take place via the FDA’s Electronic Submissions Gateway (ESG). The ESG is a secure exchange point for the FDA and its partners to interact. However, only individuals possessing trusted digital certificates will be able to use the ESG successfully.
Life sciences organizations face a choice. They can devote the time and resources necessary to create their own Certificate Authority (CA) to issue and maintain digital certificates for their employees and those of their partners needing to engage the FDA’s ESG. Or, they can turn to a trusted third-party.
At least one company, Exostar, feels they have acted with foresight to position themselves to assist life sciences organizations meet the FDA’s digital certificates requirements. Exostar, whose cloud-based solutions help companies in aerospace and defense, life sciences, and healthcare collaborate securely with their partners, today announced its recognition by the Food and Drug Administration (FDA) as a proven provider of digital certificates that validate the authenticity of electronic documents and their owners. Digital certificates are poised to become a top priority for life sciences organizations, given a pending deadline issued by the FDA.
“The FDA’s pending deadline represents a milestone that will bring significant long-term benefits to the agency, the life sciences industry, and consumers. It also reflects a commitment to better securing intellectual property and personally identifiable information,” said Matthew Williams, Exostar’s Product Manager of Identity and Access Management Solutions. “We can help life sciences organizations comply without losing focus on their drug development missions. With a track record that includes a leading identity management role for TransCelerate BioPharma, as well as the issuance and maintenance of over 200,000 credentials for more than 3,000 life sciences organizations worldwide, Exostar is the de-facto identity provider for the life sciences market.”
Steven Bowcut, CPP, PSP is Editor-in-Chief for Brilliance Security Magazine.