Guidelines & Products – Search Results – Page 13 – ICH

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Harmonised

E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

In Process

E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

Pre-harmonisation

E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

Harmonised

E2D(R1) – Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

In Process

E2D(R1) – Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

Pre-harmonisation

E2D(R1) – Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

Harmonised

E2E – Pharmacovigilance Planning

In Process

E2E – Pharmacovigilance Planning

Pre-harmonisation

E2E – Pharmacovigilance Planning

Harmonised

E2F – Development Safety Update Report

In Process

E2F – Development Safety Update Report

Pre-harmonisation

E2F – Development Safety Update Report

Harmonised

E3 – Structure and Content of Clinical Study Reports

In Process

E3 – Structure and Content of Clinical Study Reports

Pre-harmonisation

E3 – Structure and Content of Clinical Study Reports

Harmonised

E4 – Dose-Response Information to Support Drug Registration

In Process

E4 – Dose-Response Information to Support Drug Registration

Pre-harmonisation

E4 – Dose-Response Information to Support Drug Registration

Harmonised

E5 – Ethnic Factors in the Acceptability of Foreign Clinical Data

In Process

E5 – Ethnic Factors in the Acceptability of Foreign Clinical Data

Pre-harmonisation

E5 – Ethnic Factors in the Acceptability of Foreign Clinical Data

Harmonised

E6 – Good Clinical Practice (GCP)

In Process

E6 – Good Clinical Practice (GCP)

Pre-harmonisation

E6 – Good Clinical Practice (GCP)