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

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) 

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.

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

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

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.