2022 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures

Report from the meeting held on 23-25 May 2023 Report from the meeting held on 24-25 April 2023 Report from the meeting held on 28-30 March 2023 Report from the meeting held on 21-22 February 2023 Report from the meeting held on 24-26 January 2023

A Step 2 Informational Presentation has been developed by the M13 Expert Working Group, in follow up to the ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reaching Step 2b of the ICH Process in December 2022.

The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process on 16 November 2022.

Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU Reference Date is not yet legally binding (March 2017) 

CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure) (November 2024) [Track version] 

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 M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) EWG will be co-leading a public webinar on Thursday 26 January 2023 from 10:00 a.m. – 12:00 p.m. EST hosted by the Clinical Trials Transformation Initiative.

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