On April 1st, 2024, the US Food and Drug Administration (FDA) introduced a significant update in pharmaceutical regulations with the release of the final guidance titled "Providing Regulatory Submissions in Electronic Format: IND Safety Reports." This guidance addresses the electronic submission requirements for investigational new drug application (IND) safety reports, aiming to streamline the process and enhance regulatory efficiency.
Key Highlights of the US FDA Guidance on IND Safety Reports:
The regulation 21 CFR 312.32(c)(1)(i) mandates sponsors to submit IND safety reports for serious and unexpected suspected adverse reactions. The new guidance outlines the electronic format sponsors must use when submitting these reports to the FDA. It supersedes certain aspects of the previous guidance while retaining other relevant sections.
Starting from April 1st, 2026, IND safety reports must be submitted to the FDA Adverse Event Reporting System (FAERS) on a mandatory basis. Until then, sponsors have the option to submit reports to FAERS voluntarily, following the existing eCTD guidance.
The guidance specifies the types of adverse reactions to be reported, including serious and unexpected events observed during clinical trials, bioavailability studies, bioequivalence studies, and more. It outlines the timelines for reporting, which vary depending on the severity and unexpectedness of the adverse reaction.
Exemptions and Waivers for certain IND Safety Reports:
The guidance provides exemptions and waivers for certain types of investigational new drug applications, particularly noncommercial INDs intended for non-commercial distribution. While these INDs are exempted, sponsors may still choose to submit safety reports through FAERS voluntarily.
Electronic Submission Platforms:
Sponsors are encouraged to utilize electronic submission gateways such as the Electronic Submission Gateway (ESG) and the Safety Reporting Portal (SRP) for submitting IND safety reports. The guidance includes technical conformance guides and regional implementation guides to facilitate electronic transmission of safety reports.
The release of the final guidance on IND safety reports marks a significant step towards modernizing regulatory submissions in the pharmaceutical industry. By standardizing electronic submission formats and streamlining reporting processes, the FDA aims to enhance regulatory oversight and ensure timely assessment of safety data. Pharmaceutical companies must familiarize themselves with the new requirements and leverage electronic submission platforms to comply with regulatory obligations effectively.
For pharmaceutical companies seeking expert guidance and support in navigating regulatory compliance, Artixio offers comprehensive services tailored to meet industry requirements. Reach out to us today to ensure seamless adherence to pharmaceutical regulations and optimize your regulatory submission processes.