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.

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.

The ICH Q9(R1) Guideline on Quality Risk Management has reached Step 4 of the ICH Process on 18 January 2023.

Meeting 20-21 June: Agenda Meeting 23-25 May: Agenda Meeting 24-25 April: Agenda - Minutes Meeting 28-30 March: Agenda - Minutes Meeting 21-22 February: Agenda - Minutes Meeting 24-26 January: Agenda - Minutes

Meeting 23-25 May: Agenda Meeting 24-25 April: Agenda Meeting 28-30 March: Agenda - Minutes Meeting 21-22 February: Agenda - Minutes Meeting 24-26 January: Agenda - Minutes

Methotrexate Date of pulication: 05/01/2023

The ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reached Step 2 of the ICH process on 20 December 2022.

Added in December 2022 22 December NEW - Report from the meeting held on 13-14 December  19 December NEW - 8-10 November CMDh Minutes 16 December UPDATE - Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh 15 December NEW - 13-14 December CMDh Agenda 5 December 2022 UPDATE [...]

The Assembly of the International Council for Harmonisation (ICH) met in-person on the 15 - 16 November 2022, in Incheon, Republic of Korea in parallel of meetings of ten Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.

Euvax B (Vaccinum hepatitidis B (ADNr)) End of procedure: 12/10/2022 Date of publication: 16/11/2022