FDA's new guidance: how to understand when some ind safety reports are no longer submitted using ectd?

Recently, FDA issued an electronic format to submit the draft safety reporting guidelines for new drugs for clinical research (ind) The sponsor is required to submit the serious and unexpected suspicious adverse event safety reports of ind to the FDA adverse event reporting system (faces) 24 months after the final release of the guidelines What are the reasons for this provision? Which submissions are specifically involved? Source: reference [1] In accordance with current requirements, FDA requires that these reports be submitted in electronic common technical document (ectd) in PDF format However, the review and tracking of these documents are inefficient and labor-intensive Therefore, the FDA requires that these important safety information be submitted to foers as structured data elements, which will help to improve the FDA's ability to review and track potential safety signals during clinical trials, and provide the sponsor with the required reporting format that meets the requirements of ICH e2b (R3) and reports to other regulatory agencies The change of relevant submission requirements is part of FDA's specific implementation of electronic submission requirements specified in section 745a (a) of the federal food, drug and Cosmetic Act The FDA said that the sponsor can continue to submit the relevant ind safety report through the ectd; however, the sponsor can voluntarily submit the report to the faces before the request takes effect However, once the final version of the guidelines comes into effect, FDA will require the submission of ind safety reports to comply with the provisions of the new guidelines, replacing the relevant provisions of the industry guidelines (see the figure below) issued in January 2019 on the submission of some applications and related submissions of human drugs in accordance with the ectd specifications Source: reference [2] According to the guidance, the sponsor must submit the related ind security report to the faces through the electronic submission gateway (ESG) or safety reporting portal (SRP) of FDA The newly published draft guidelines do not apply to ind safety reports other than serious and unexpected suspected adverse events, such as reports detailing results from other studies, results from laboratory animals or in vitro tests, or reports of increased incidence of serious suspected adverse events In addition, the FDA said that although the FDA encourages the sponsor to submit electronically, non-commercial ind submissions will be exempt from the electronic submission requirements set forth in section 745a (a) In addition to the draft guide, as a supplement to the draft guide, FDA also issued a separate technical compliance guide detailing the individual case safety reports (icsrs) to be submitted to FDA in the format of ectd and the format of ind safety reports to be submitted to faces Source: reference [3] ▲ type and submission method of ind safety report (data source: reference [3], prepared by content team of Wuxi apptec) The FDA is seeking advice from the pharmaceutical industry and stakeholders on the draft guidance, which is due by the end of this year reference material: [1] FDA Guidance Document Providing Regulatory Submissions in Electronic Format: IND Safety Reports （Guidance for Industry） Oct, 2019 Retrieved Nov 1, 2019 from https:// [2] FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Jan, 2019 Retrieved Nov 1, 2019 from https:// [3] FDA Guidance for Industry ELECTRONIC SUBMISSION OF IND SAFETY REPORTS TECHNICAL CONFORMANCE GUIDE Oct, 2019 Retrieved Nov 1, 2019 from https:// [4] 21 CFR § 312.32 - IND safety reporting Retrieved Nov 1, 2019 from https:// [5] Michael Mezher FDA to require certain IND safety reports be submitted to FAERS Oct 31, 2019 Retrieved Nov 1, 2019 from https://endpts.com/fda-to-require-certain-ind-safety-reports-be-submitted-to-faers/ A kind of