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2022/8/16: FDA: ICH E2B(R3)での治験 (IND: BA/BE) 個別有害事象電子報告に関連する各種レギュレーション・ドキュメント August-2022付で改訂FDA: updated ICH E2B(R3) Documents at Adverse Event Reporting System (FAERS) Electronic Submissions Website

HiroPharmaConsulting Newsletter Vol.4 No.5をアップいたしました。

今回は、米国(FDA)FAERS Web Siteの2022年8月16日(火)の更新情報のご案内です。

ICH E2B(R3)での治験(IND: BA/BE)個別有害事象電子報告に関連する、以下の各種レギュレーション・ドキュメントが、August-2022付で更新されました。

Pre-Marketing: 4-Documents and Postmarketing: 3-Documentsが更新対象です。

FDA Adverse Event Reporting System (FAERS) Electronic Submissions

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

 

[Pre-Marketing Safety Reporting]

  1. a) 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 (August 2022)
  2. b) Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry (August 2022)
  3. c) FDA E2B(R3) Core and Regional Data Elements and Business Rules (Excel file August 2022)
  4. d) FDA ICSR XML Instances (zip file August 2022)

[Postmarketing Safety Reporting: PMS]

  1. e) 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 (August 2022)
  2. f) FDA E2B(R3) Core and Regional Data Elements and Business Rules (Excel file August 2022)
  3. .
  4. g) FDA ICSR XML Instances (zip file August 2022)

“———————(以下 FDA Websiteから一部引用:強調はHiroPharmaConsultingによる)———————————–

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 Providing Regulatory Submissions in Electronic Format:  IND Safety Reports – Draft Guidance for Industry(October 2019)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 August 2022)
  6. FDA ICSR XML Instances(zip file August 2022)

 

———————(上記までFDA Websiteから一部引用)———————————–“

 

“———————(以下 FDA Websiteから一部引用:強調はHiroPharmaConsultingによる)———————————–

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 August 2022)
  3. FDA E2B(R3) Forward Compatible Rules(Excel file April 2022)
  4. FDA ICSR XML Instances(zip file August 2022)
  5. Providing Submissions in Electronic Format – Postmarketing Safety Reports: Guidance for Industry(April 2022)

 

———————(上記までFDA Websiteから一部引用)———————————–“