Blog 1

Name of Guidance: E2B(R) Revision of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

Status of Guidance: Draft Guidance

When was the Guidance released?
This guideline was originally signed off July 17, 1997 and modified as E2B(M) guideline in November 2000. The E2B(R) was released 12 May 2005.

Link to the Guidance http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073096.pdf

Target audience: pharmaceutical companies, regulatory authorities, ethics committees

Laws and Regulations Referenced (and what each law states in relevant part}
World Health Organization – Collaborating Center for International Drug Monitoring
ICH E2A and E2D guidelines for life-threatening and other medically important conditions

Summary
This guidance objective is to standardize data elements for transmission of individual safety reports, by identifying and defining elements for the transmission of all individual safety reports, regardless of source and destination. This guidance includes the standards for data elements of safety reports for both pre and post approval periods and covers adverse drug reaction and adverse event reports.

Rationale
To standardize safety reporting.

Resulting Recommendations
This guidance will be followed for all safety reporting.

Impact
Clarifies reporting format
Provides standards for data transmission format
This standard allows for information to be transmitted in an encoded format.