Guidance Breakdown: Providing Regulatory Submissions in Electronic Format — IND Safety Reports
A new final guidance mandates electronic submission of IND safety reports for serious and unexpected suspected adverse reactions, detailing technical specs, timelines, and more.
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On April 1st, the FDA released final guidance detailing the requirements for electronic submission of investigational new drug (IND) safety reports. This guidance aims to enhance the efficiency and accuracy of safety signal reporting during clinical trials by transitioning to a fully electronic system. It outlines specific electronic formats that sponsors must use when submitting safety reports for serious and unexpected suspected adverse reactions as mandated under 21 CFR 312.32(c)(1)(i).
FDA is announcing the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” This guidance finalizes the draft guidance of the same name published on October 30, 2019 (84 FR 58158), and describes the electronic format sponsors will be required to use when they electronically submit IND safety reports to CDER and CBER for serious and unexpected suspected adverse reactions, as required under 21 CFR 312.32(c)(1)(i). FDA is establishing the electronic format requirements described in this final guidance under section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)).
The guidance establishes a comprehensive framework for electronic submissions to the FDA Adverse Event Reporting System (FAERS), including timelines for implementation, technical specifications, and procedures for waiver requests. By setting these requirements, the FDA seeks to streamline the submission process, improve the review and tracking of safety signals, and align with international standards for safety reporting.
This move represents a significant shift towards leveraging technology to enhance regulatory compliance and patient safety oversight. The guidance specifies the formats and standards for electronic submissions. It clarifies the scope of submissions, including exemptions and the types of reports that require adherence to the new electronic submission protocols.
In case your time is short, here's a quick summary of its policy contents, along with our recommendations for action.
Who’s impacted by this guidance
Sponsors of Clinical Trials: Companies that sponsor clinical trials under Investigational New Drug Applications, including those developing drugs and biologics, are directly affected. This encompasses many entities, from large pharmaceutical companies to smaller biotech firms actively engaged in drug development.
CROs: CROs that manage drug development processes and clinical trials on behalf of sponsors must also comply with these electronic submission requirements, as they often handle regulatory submissions.
Biotechnology Companies: Smaller biotech firms, particularly those in the early stages of drug development, must align with these requirements for their IND safety reports. This guidance may necessitate changes in collecting, managing, and reporting safety data.
Academic Institutions: Universities and academic research centers conducting clinical trials under INDs must adhere to the electronic submission guidelines, especially those with commercial aspirations for their investigational products.
Start-Ups and Emerging Pharma: Start-up companies and emerging pharmaceutical firms engaged in developing new drugs or biologics under INDs should closely follow this guidance to ensure compliance in their drug development processes.
Regulatory Affairs Consultants and Service Providers: Entities providing regulatory consultancy and submission services to drug developers must be well-versed in these requirements to assist their clients in complying with the FDA's electronic submission mandates.
Investigator-Sponsored IND Holders: While the guidance exempts noncommercial INDs, including investigator-sponsored and expanded access INDs (such as emergency use INDs and treatment INDs), from the electronic submission requirements, the FDA encourages the use of the specified electronic format for consistency and efficiency. Therefore, investigators holding these types of INDs may also consider adhering to the guidance.
International Pharmaceutical Companies: Global firms with clinical trials under IND in the United States must comply with this guidance for their U.S.-based studies. This includes companies headquartered outside of the U.S. but conducting or planning to conduct clinical research within U.S. jurisdiction.
Introduction and background
This FDA guidance mandates that sponsors must electronically submit IND safety reports for serious and unexpected suspected adverse reactions as required under 21 CFR 312.32(c)(1)(i).
Under the Federal Food Drug and Cosmetic Act section 745A(a), this shift to electronic submissions supersedes relevant sections of previous eCTD guidance, specifically for the electronic submission of IND safety reports within this scope. The guidance references additional technical specifications for formatting electronic submissions to the FAERS.
Under section 745A(a) of the FD&C Act, certain submissions, including IND safety reports, must now be electronically submitted. This move aims to enhance the FDA's review capabilities by improving the tracking and analysis of safety signals during clinical trials, aligning with ICH guidelines and regulatory reporting standards.
Scope of this guidance
A. Types of Submissions Required for Electronic Submission: This guidance specifically applies to IND safety reports for serious and unexpected suspected adverse reactions under 21 CFR 312.32(c)(1)(i), encompassing both 7- and 15-day reporting requirements based on event severity.