Regulatory agencies like the United States’ FDA are increasingly encouraging electronic submission of Investigational New Drug (IND) safety reports. Electronic submission has numerous advantages over traditional paper-based submissions such as efficiency, accuracy, accessibility, timeliness and standardization. IND clinical trial sponsors are required to submit the IND safety report of serious and unexpected suspected adverse reactions to the US FDA within 7 or 15 calendar day depending on the seriousness of the adverse event. Earlier these reports were submitted as MedWatch Form FDA 2500A or CIOMS I Forms (or other narrative forms). Having these reports submitted as structured data elements via electronic submissions enhances the Agency’s review process and facilitates better tracking of potential safety signals. This in turn provides IND trial sponsors with a consistent reporting format in accordance with ICH guidelines & reporting requirements.
Regulatory Submissions in Electronic Format: IND Safety Reports
The US FDA has announced 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 This guidance finalizes the draft guidance of the same name published on October 30, 2019.
- The guidance applies to IND safety reports for serious and unexpected suspected adverse reactions as outlined in 21 CFR 312.32(c)(1)(i).
- It does not apply to other types of safety reports or INDs for non-commercial purposes.
- The document describes specific types of submissions that fall within or outside its scope.
To improve safety reporting procedures and guarantee conformity to rules, the Food and Drug Administration (FDA) made it compulsory for sponsors to follow set electronic formatting standards when handing in their investigational new drug application (IND) safety reports on serious and unexpected suspected adverse reactions. It was established under section 745A (a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to enhance the efficiency and effectiveness of safety reporting processes.
The transition to electronic submissions will become effective 24 months after the publication of the guidance in the Federal Register (anticipated April 1, 2026).
According to the FD&C Act, sponsors who conduct clinical trials under an IND are required to notify the FDA about serious and unexpected suspected adverse reactions within specified time frames. These reports which were traditionally submitted on narrative forms, will now be submitted to FDA Adverse Event Reporting System (FAERS) in structured electronic formats. This change is in line with International Council for Harmonisation (ICH) standards which aim at improving safety signal detection in clinical trials.
What are the requirements for electronic submission?
Sponsors are required to submit IND safety reports to the FDA Adverse Event Reporting System (FAERS) using either the Electronic Submission Gateway (ESG) or the Safety Reporting Portal (SRP). Sponsors utilizing ESG should refer to the FDA Data Standards Catalog for information on the ICH E2B data standard. Additional technical specifications and instructions for submission can be found in the Electronic Submission of IND Safety Reports: Technical Conformance Guide and the FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products. Before the initial submission to FAERS, sponsors must create an account with the FDA.
What are some of the pre-submission considerations?
Before submitting IND safety reports to FAERS, sponsors should establish an account with the FDA. This process involves coordination with the FAERS electronic submission coordinator and may include optional test submissions to ensure compliance. While waivers from electronic submission requirements are rare, sponsors may request temporary waivers under exceptional circumstances, such as natural disasters or internet disruptions.
Waiver Requests
FDA may grant temporary waivers for certain circumstances such as extraordinary events or prolonged internet disruptions that are preventing electronic submission. Requests for waivers should include relevant details and be submitted to designated FDA email addresses.
Conclusion
The US FDA’s dedication to streamlining regulatory procedures and strengthening drug safety monitoring is illustrated by the new requirement that IND safety reports be submitted electronically. This change will allow for easier reporting, better information, and timely evaluations of patient safety during clinical research studies.
DDReg provides end-to-end Clinical Trial Regulatory Services and safety solutions for a range of pharmaceutical products. Reach out to the experts for more information. Read more about INDs here: CMC considerations for human gene therapy INDs