個別症例安全安全レポート（ICSRS）のFAERSへの電子提出の更新：29-APR-2022Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS: on 29-Apr-2022

FDA ICH E2B(R3) Regulation<FDA:
Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS: on 29-Apr-2022>

お客さま　各位
いつもお世話になっております。ヒロファーマコンサルティングの集です。(updated on 3-May-2022)
さて、今般FDAにより 2022年4月29日（金）付けでICH E2B(R3)関係のドキュメントの更新が行われました。

まずは速報ですが、更新情報のサマリーを以下にまとめました。

特に Premarketing-3), Postmarketing-1)「同じ」は、FDA ICH E2B(R3)における 「ICSR電子報告の実装におけるガイドライン」　が規定されており、現在質問コメントがあれば、FDA FAERS へ提出できるようになっています。

（なお、2022/5/1現在リンク先の Excel file/ zip file先が Page Not Foundとなっていますので FDA FAERS Teamに確認中です）

（2022/5/3 FDA FAERS Teamより Not Foundの修復完了の連絡がありましたので、Excel file, zip file Downloadが可能になっています。）

今後FDA向けに ICH E2B(R3) ICSR Electronic Submissionを計画されているお客様におかれましては、「今回の発出内容」と「FDA実装ガイドライン」、及び 「FDA Regional Tag Requirements：いわゆる FDA Tag」を再度「PV: Pharmacovigilance System提供Vendor様」へお問い合わせいただき、既存でご使用中PVシステムVersionのFDA実装状況の確認をされることをお薦めいたします。

さて、今回のFDAの提示内容からの推測になりますが、一昨年来実施されてきた FDA FAERS Version-up ProjectのICH E２B(R3)対応が、ようやく実装段階に入ったと考えられます。当初計画よりは遅れておりますが、2022年になって本件含め具体的なレギュレーションの整理と最終化が行われてきております。これらの状況から、まだ正式な FDA E2B(R3)電子報告開始と、暫定期間は発出されておらず以下の Noteが提示されていますが、CY2022年度3Q-4Qには何らかの続報がある可能性があります。引き続き注視していきたいと思っております。

取り急ぎ初報のお知らせです。集（HiroPharmaConsulting）

“Please note that FDA is not currently accepting submission of postmarketing ICSRs in ICH 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.”

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

Premarketing Safety Reporting:

1) Providing Regulatory Submissions in Electronic Format:
IND Safety Reports Guidance for Industry DRAFT GUIDANCE
October 2019 Electronic Submissions
Download file : “28957842dft.pdf”

2) ELECTRONIC SUBMISSION OF IND SAFETY REPORTS TECHNICAL CONFORMANCE GUIDE
April 2022
Download file : “50104656fnl_Electronic Submission of IND Safety Reports.pdf”

3) FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for
Drug and Biological Products
Guidance for Industry
Technical Specifications Document
April 2022 ICH
Download file : “FDA Regional Implementation Guide for E2B-R3_0.pdf”

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-regional-implementation-guide-e2br3-electronic-transmission-individual-case-safety-reports-drug

Postmarketing Safety Reporting:

1) FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
Guidance for Industry
Technical Specifications Document
April 2022 ICH
Download file : “FDA Regional Implementation Guide for E2B-R3_0.pdf”

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-regional-implementation-guide-e2br3-electronic-transmission-individual-case-safety-reports-drug

5) Providing Submissions in Electronic Format— Postmarketing Safety Reports
Guidance for Industry
Download file : “2180363fnl.pdf”

Top Headline Guide:

1) Guidance for Industry

    E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs)Implementation Guide – Data Elements and Message Specification
April 2022 ICH Revision 1
Download file : “50627847fnl_Implementation Guide.pdf”

2) Guidance for Industry
Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide
Backwards and Forwards Compatibility
April 2022 ICH Revision 1
Download file : “50627847fnl_Appendix I B.pdf”

<Downloaded Excel file and zip file/ Unzipped>

“FDA-E2B(R3)-Core-and-Regional-Data-Elements-and-Business-Rules.xlsx”
“FDA-E2B(R3)-Forward-Compatible-Rules.xlsx”
“FDA-ICSR-XML-Instances.zip”
“XML Instance – Read Me.txt”
“FAERS2022Scenario1.xml”
“FAERS2022Scenario2.xml”
“FAERS2022Scenario3.xml”
“FAERS2022Scenario4.xml”
“FAERS2022Scenario5-1.xml”
“FAERS2022Scenario5-2.xml”
“FAERS2022Scenario5-3.xml”
“FAERS2022Scenario6.xml”
“FAERS2022Scenario7.xml”

“———————-(original FDA Web Site on 29-Apr-2022)———————————————————————-“

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, 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. FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products(April 2022)
4. FDA E2B(R3) Core and Regional Data Elements and Business Rules(Excel file April 2022)
5. FDA ICSR XML Instances(zip file April 2022)

Please note that FDA is not currently accepting submission of premarket ICSRs in the E2B(R3) format. Please continue to submit IND Safety Reports using eCTD format. FDA will update this web page when final guidance is published, and FDA will accept IND and IND-exempt bioavailability/bioequivalence (BA/BE) safety reports in E2B(R3) format. FDA will also update this web page to communicate when submission of safety reports in E2B(R3) format is required for certain IND and IND-exempt BA/BE studies, 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(April 2022)
2. FDA E2B(R3) Core and Regional Data Elements and Business Rules(Excel file April 2022)
3. FDA E2B(R3) Forward Compatible Rules(Excel file April 2022)
4. FDA ICSR XML Instances(zip file April 2022)
5. Providing Submissions in Electronic Format – Postmarketing Safety Reports: Guidance for Industry(April 2022)

Please note that FDA is not currently accepting submission of postmarketing ICSRs in ICH 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.

Dear Customers (in English)  <Updated on 3-May-2022>
Thank you for your continuous support as always. Hiro Atsumaru (HiropharmaConsulting).
The FDA has updated the ICH E2B (R3) specification documentation as of Friday, April 29, 2022.
First of all, the summary of the updated information is summarized below.
In particular, Documents such as “Premarketing -3 ”,“ Postmarketing -1 ” and “the same ” are defined in the“ Guidelines for Implementing ICSR Electronic Reporting ” of the FDA ICH E2B (R3), and it is now possible to submit comments with questions.

(2022/5/1: Currently, the linked Excel file/zip file destination is Page Not Found, so we are checking with FDA FAERS Team.) (updated on 2022/5/3: it was resolved by FDA  FAERS Team)

If you are planning an ICH E2B (R3) ICSR Electronic Submission for FDA, we recommend that you contact “PV: Pharmacovigilance System Vendor ” again to confirm the FDA implementation status of your existing PV system version by referring to“ This Issue ”, “FDA Implementation Guidelines ”, and “FDA Regional Tag Requirements: so-Called FDA Tags”.

Based on the FDA’s presentation, it is assumed that the FDA FAERS Version-up Project for ICH E2B (R3) has finally entered the implementation stage. Although it has been delayed from the initial plan, specific regulations including this matter have been organized and finalized since 2022. In light of these circumstances, the FDA has not yet formally initiated FDA E2B (R3) and issued the interim period, and the following Note has been presented. However, there is a possibility that there will be some further information in FY 2022 3 -4 Q. We will continue to monitor the situation closely.

This is the first quick Newsletter. Hiro Atsumaru (HiroPharmaConsulting)

Hirotsugu Atsumaru (Hiro)
HiroPharmaConsulting® Co., Ltd.
Representative Director
Email: hiro_atsumaru@hiropharmaconsulting.com
Mobile: +81-80-5699-3284 (080-5699-3284: Japan)