今般、FDA FAERS Websiteの一部アップロードファイル： “FDA ICSR xml for E2B(R3) zip file” が、2023年9月13日で更新されました。The partial upload of the "FDA ICSR xml for E2B (R3) zip file" on the FDA FAERS Website was updated on 13th September 2023.

お客さま　各 位

今般、FDA FAERS Websiteの一部アップロードファイル： “FDA ICSR xml for E2B(R3) zip file” が、2023年9月13日で更新されました。

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions

6. FDA ICSR XML Instances(zip file September 2023)　　  –> < for Premarketing Safety Reporting >

4. FDA ICSR XML Instances(zip file September 2023)        –> < for Postmarketing Safety Reporting >

今回は、E2B(R3) ICSR向けの Scenario Sample xmlの更新版がアップされています（Premareting & Postmarketing用）

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Title: This document lists the scenarios provided as FDA ICSR XML Instance and acknowledgement examples based on FDA ICH E2B(R3) Technical Specifications Document.

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History of Changes:

—————–   ———–   ——————————————————————-

Date                     Version       Description

—————–   ———–   ——————————————————————-

Apr 25, 2022          1.0            Initial – Scenarios created

Dec 23, 2022          1.1                Causality values updated to “Suspected” or “Not Suspected” for Scenario 3 and 4 updated 

                                                     Added acknowledgement samples.

List of Scenarios:

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Scenario 1:  Manufacturer submits postmarket drug report containing 3 drugs that does not include any combination products. There was an Adverse Event. (FAERS2022Scenario1.xml)

Scenario 2:  Manufacturer submits postmarket drug report containing 3 drugs where one drug is combination product.There was an Adverse Event and Malfunction. (FAERS2022Scenario2.xml)

Scenario 3:  Manufacturer submits premarket IND safety report containing 3 drugs product where one product is the IND where the AE occured. (FAERS2022Scenario3.xml)

Scenario 4:  Manufacturer submits AGGREGRATE premarket IND safety report with the parent IND number. (FAERS2022Scenario4.xml)

Scenario #5-1:  A person(s) conducting IND-exempt bioavailability/bioequivalence studies submit(s) a premarket safety report containing products from the pre-ANDA where the AE occurred. (FAERS2022Scenario5-1.xml)

Scenario #5-2:  A person(s) conducting IND-exempt bioavailability/bioequivalence studies submit(s) a premarket safety report from the pre-ANDA where the AE occurred. (FAERS2022Scenario5-2.xml)

Scenario #5-3:  A person(s) conducting IND-exempt bioavailability/bioequivalence studies submit(s) a premarket safety report from the pre-ANDA where the AE was observed during the run-in phase. (FAERS2022Scenario5-3.xml)

Scenario 6 :  A mega postmarket instance file, containing all elements. (FAERS2022Scenario6.xml)

Scenario 7:  An example containing a “similar device” malfunction scenario for a device component. (FAERS2022Scenario7.xml)

Positive acknowledgement: An example of a positive acknowledgement file. (R3ack-positive.ack)

Negative acknowledgement: An example of a negative acknowledgement file. (R3ack-negative.ack)

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お客様　各位

さて、今回の ICSR xml zipの更新内容と、FDA ICH E2B(R3) Reportingの開始時期に関して FDA/ FAERS窓口に問い合わせてみました。

その返事が以下になります。依然として E2B(R3) Reporting 受理開始時期は公表されていないとの回答です。

—————– ( 2023/09/15 (Fri) 3:01 from FDA FAERS Team) —————

The E2B R3 XML instance files were updated to correct some tags. Currently FDA is updating the FAERS system to incorporate E2B R3 and no final date has been published. We plan to provide our progress in the next public meeting on electronic submission to be held virtually on Nov 7. More information about this meeting will be posted at https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using

ただし、FDAからの参考情報として、2023年11月 7日に、「FDA電子報告の公開ミーティング」 がリモートで開催されるますのでお知らせ致します。

このミーティングで、FAERS version-up for ICH E2B(R3) Reportの最新の進捗状況と、E2B(R3)の開始予定が報告されるようです。

FDA ICH E2B(R3) Reportにご興味・関心のある皆様は、ご参加頂けましたら有用な最新情報が得られるかと思います。

https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using

Dates and Times:

Upcoming Meetings:
To be held virtually, by webcast only.

November 7, 2023, from 9:00 a.m. – 12:00 p.m.

Webcast Information:

November 7, 2023 meeting: To be provided.

Registration:

This website will be updated to confirm when registration is open for the second public meeting scheduled for November 7, 2023.

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Dear Customer,

Now, I have contacted the FDA/FAERS contact regarding the latest ICSR xml zip update and when to start FDA ICH E2B (R3) Reporting.

Here is the reply:. The response is still that the date for the start of accepting E2B (R3) Reporting has not been announced.

——————– ( 2023/09/15 (Fri) 3:01 from FDA FAERS Team) —————-

The E2B R3 XML instance files were updated to correct some tags. Currently FDA is updating the FAERS system to incorporate E2B R3 and no final date has been published. We plan to provide our progress in the next public meeting on electronic submission to be held virtually on Nov 7. More information about this meeting will be posted at https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using

However, for reference information from the FDA, we would like to inform you that on November 7, 2023, the “FDA Electronic Reporting Public Meeting” will be held remotely.

It appears that the meeting will provide an update on the progress of the FAERS version-up for the ICH E2B (R3) Report and the expected launch of E2B (R3).

If you are interested and interested in the FDA ICH E2B (R3) Report, please join us for useful updates.

https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using

Dates and Times:

Upcoming Meetings:
To be held virtually, by webcast only.

November 7, 2023, from 9:00 a.m. – 12:00 p.m.

Webcast Information:

November 7, 2023 meeting: To be provided.

Registration:

This website will be updated to confirm when registration is open for the second public meeting scheduled for November 7, 2023.

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The partial upload of the “xml for E2B (R3) zip file” on the FDA FAERS Website was updated on 13^th September 2023.

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions

Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS

FDA recently updated the following guidances for industry to incorporate technical updates: E2B (R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide – Data Elements and Message Specification and Appendix to the Implementation Guide — Backwards and Forwards Compatibility.

Premarketing Safety Reporting

In preparation for the electronic transmission of premarketing safety reports in the International Council for Harmonisation (ICH) E2B(R3) format, FDA has posted the following documents regarding the electronic submission of ICSRs for certain investigational new drug application (IND) safety reports for drug and biological products and IND-exempt bioavailability/bioequivalence (BA/BE) safety reports to FAERS. These documents are posted to help sponsors prepare their systems for electronic submission of IND safety reports in the E2B(R3) format.

1. Providing Regulatory Submissions in Electronic Format:  IND Safety Reports – Draft Guidance for Industry(October 2019)
2. Electronic Submission of IND Safety Reports – Technical Conformance Guide(April 2022)
3. Technical Specifications Document – FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products(August 2022)
4. Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies – Draft Guidance for Industry(August 2022)
5. FDA E2B(R3) Core and Regional Data Elements and Business Rules(Excel file June 2023)
6. FDA ICSR XML Instances(zip file September 2023)

Please note, FDA is not currently accepting the submission of premarket ICSRs in the E2B(R3) format. Please continue to submit IND safety reports using eCTD format and IND-exempt BA/BE safety reports on Form FDA 3500A. FDA will update this web page when final guidance for IND safety reporting is published, and when FDA will accept IND and IND-exempt BA/BE safety reports in E2B(R3) format on a voluntary basis. FDA will also update this web page to communicate when submission of safety reports in E2B(R3) format is required for certain INDs after the period of voluntary submission.

Postmarketing Safety Reporting

In preparation for the receipt of postmarketing safety reports in the E2B(R3) format, FDA has posted the following documents regarding the electronic submission of safety reports for drug and biological products to FAERS. These documents are posted to help prepare systems for electronic submissions of postmarketing safety reports.

1. Technical Specifications Document – FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products(August 2022)
2. FDA E2B(R3) Core and Regional Data Elements and Business Rules(Excel file June 2023)
3. FDA E2B(R3) Forward Compatible Rules(Excel file April 2022)
4. FDA ICSR XML Instances(zip file September 2023)
5. Providing Submissions in Electronic Format – Postmarketing Safety Reports: Guidance for Industry(April 2022)

Please note, FDA is not currently accepting the submission of postmarketing ICSRs in the E2B(R3) format. FDA will update this web page when postmarketing ICSRs will be accepted in the E2B(R3) format. In the meantime, please continue to submit postmarketing ICSRs in the E2B(R2) format.

For questions related to this update, please contact the FAERS electronic submission coordinator at faersesub@fda.hhs.gov.