E2A - E2F Pharmacovigilance
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
The ICH Harmonised Guideline was finalized under Step 4 in October 1994. This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.
Date of Step 4: 27 October 1994
Status: Step 5
Guidelines (Click the links below for complete guidelines)
E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs)
ICH E2B EWG was re-formed to conduct a revision of E2B(R2) Guideline in 2003 and in May 2005 a revised Guideline, E2B(R3), was released for public consultation.
The ICH Steering Committee had taken a key decision that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs) to enable wider inter-operability across the regulatory and healthcare communities.
ICH E2B(R3) was the first topic harmonized under the new process. An Implementation Guide for E2B(R3) data elements and message specification was developed by the E2B EWG, which uses the ISO/HL7 27953-2 ICSR message exchange standard developed by the SDOs, and E2B(R3) reached Step 4 in November 2012.
The E2B(R3) Implementation Package, Q&As and further information is available on the ESTRI page.
Date of Step 4: 1 November 2012
Status: Step 5
E2B(R3) Q&As Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
In July 2013, the ICH Steering Committee endorsed the establishment of the IWG on E2B(R3) to assist with the implementation of the E2B(R3) Implementation Guide (published in July 2013) and help facilitate transition from E2B(R2) to E2B(R3). Included in its tasks is support for the use of constrained ISO IDMP terminologies in ICSRs, as well as maintenance of technical documents related to E2B(R3).
In November 2014, the IWG finalized the first version of Questions & Answers (Q&As) to clarify questions and comments for E2B(R3) implementation. The E2B(R3) Implementation Package, Q&As and further information is available on the ESTRI page.
Date of Step 4: 1 June 2019
Status: Step 5
Questions & Answers (Click the links below for complete guidelines)
E2B(R3) Q&As Questions & Answers
Endorsed Documents (Click the links below for complete guidelines)
E2B(R3) EWG/IWG Electronic Transmission of Individual Case safety Reports (ICSRs)
In July 2013, the ICH Steering Committee endorsed the establishment of the IWG on E2B(R3) to progress implementation activities and ensure transition from E2B(R2) to E2B(R3). The E2B(R3) Implementation Package, Q&As and further information is available on the ESTRI page.
Endorsed Document (Click the links below for complete guidelines)
E2C(R2) Periodic Benefit-Risk Evaluation Report
The ICH Harmonised Guideline was finalized under Step 4 in November 1996. This document gives guidance on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed. The Guideline is intended to ensure that the worldwide safety experience is provided to authorities at defined times after marketing with maximum efficiency and avoiding duplication of effort.
Based on the comments made by the members of the Expert Working Group on CIOMS V recommendations and the PhRMA-EFPIA working document, an addendum has been finalized and reached Step 4 in February 2003 (R1).
The revised (R2) Guideline reached Step 4 of the ICH process in November 2012. The purpose of this Guideline’s revision is to ensure that the periodic safety update reports for marketed drugs have the role of being periodic benefit-risk evaluation reports by covering: safety evaluation, evaluation of all relevant available information accessible to marketing authorization holders (MAHs) and benefit-risk evaluation.
Date of Step 4: 17 December 2012
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
E2C(R2) Q&As Questions & Answers: Periodic Benefit-Risk Evaluation Report
The revision E2C(R2) to E2C has introduced new concepts and principles linked to an evolution of the traditional PSUR from an interval safety report to cumulative benefit-risk report and with a change in focus from individual case reports to more aggregate data evaluation.
This supplementary Questions and Answers document finalized under Step 4 in March 2014 intends to facilitate practical implementation of the PBRER, including points to consider in addressing some of the more novel aspects of the new periodic safety report.
Date of Step 4: 31 March 2014
Status: Step 5
Questions & Answers (Click the links below for complete guidelines)
E2C(R2) Q&As Questions & Answers
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
⏯ E2C(R2) Q&As Training Material
E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
The ICH Harmonised Guideline was finalized under Step 4 in November 2003. This document provides a standardized procedure for post-approval safety data management and the guidance for gathering and reporting information. This Guideline is based on the content of ICH E2A Guideline, with consideration as to how the terms and definitions can be applied in the post-approval phase of the product life cycle.
Date of Step 4: 12 November 2003
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Document (Click the links below for complete guidelines)
E2D(R1) EWG Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
This topic was endorsed by the ICH Assembly in June 2019.
The E2D(R1) EWG is working on the revision of the of the E2D Guideline “Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting” with a view to clarifying the management of post-approval safety information from new or increasingly used data sources including the need to adapt definitions and standards.
Status: Step 1
Endorsed Documents (Click the links below for complete guidelines)
E2E Pharmacovigilance Planning
The ICH Harmonised Guideline was finalized under Step 4 in November 2004.
This Guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early post-marketing period of a new drug (in this Guideline, the term "drug" denotes chemical entities, biotechnology-derived products, and vaccines).
The main focus of this Guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of license application.
Date of Step 4: 18 November 2004
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Document (Click the links below for complete guidelines)
E2F Development Safety Update Report
The ICH Harmonised Guideline was finalized under Step 4 in August 2010. The Development Safety Update Report (DSUR) proposed in this Guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The main focus of the DSUR is data and findings from interventional clinical trials (referred to as "clinical trials") of drugs and biologicals that are under investigation, whether or not they have a marketing approval.
Following the completion of the E2F Step 4 Guideline, the E2F EWG developed DSUR Examples for commercial and non-commercial sponsors to help with the use of the E2F Guideline. It should be noted that these documents are only examples and therefore did not go through the Formal ICH Procedure.
Date of Step 4: 17 August 2010
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
Deliverables (Click the links below for complete guidelines)
E2F DSUR Examples Non-Commercial Sponsors
E2F DSUR Examples Commercial Sponsors
*These Guidelines Belongs to ICH website.
ICH E2A - E2F Pharmacovigilance Guidelines:
