News Archive

ICH - ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process.

2nd February 2023

The ICH Secretariat is pleased to announce that as of 17 January 2023, the updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process.

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ICH - Quality Risk Management Q9(R1) Adopted

2nd February 2023

Final version adopted on 18th January 2023.

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ICH - The ICH M13A draft Guideline presentation available now on the ICH website

2nd February 2023

The ICH M13A draft Guideline presentation available now on the ICH website

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ICH - Training on Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports

2nd February 2023

The ICH Secretariat is pleased to announce the publication of Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports Training Video.

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ICH - Training on Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Product

2nd February 2023

The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process on 16 November 2022. Following the adoption of this Guideline, a Step 4 Introductory Training Presentation has been developed by the Q13 Expert Working Group.

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