Meeting 28-30 January 2025: Agenda

Following the adoption of the E6(R3) Guideline on 6 January 2025, a Step 4 Introductory Training Presentation has been developed by the E6(R3) Expert Working Group.

The ICH E6(R3) “Good Clinical Practice” Guideline reached Step 4 of the ICH Process on 6 January 2025.

European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) An implementation plan agreed in February 2021 sets out how the European medicines regulatory network, together with the European Directorate for the Quality of Medicines & HealthCare (EDQM), will be implementing the outcome of the Art. 5(3) referral. This includes specific measures that the network will take if nitrosamines are [...]

Questions and answers A question-and-answer document is available for marketing authorisation holders on implementing the Article 5(3) CHMP opinion. It covers the following: Outcome of the Article 5(3) referral and its relation to lessons learned exercise from nitrosamines detected in sartansPrinciples, methodology and scope for nitrosamine management in human authorised productsGuidance for establishing and reporting acceptable intake limits derived from implemented approaches: carcinogenic [...]

For additional specific information related to nationally authorised products (including MRP/DCP): CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines (July 2023) [Tracked]Template for nitrosamine risk evaluation in marketing authorisation applications

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) is very pleased to announce the appointment of Géraldine Lissalde-Bonnet as Secretary General of the ICH Secretariat based in Geneva, Switzerland.

When submitted with an eCTD, the Working Documents should always be provided in a separate folder called "xxxx-workingdocuments"

The ICH Secretariat is pleased to announce the publication of the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers (R5). The ICH Assembly approved this updated Q9(R1) Annex 1 on 30 October 2024.