Notification Form (June 2024) [PDF] [Tracked​​​​​​​]

Variation applications Cover letter for Variation Applications in the Mutual Recognition Procedure (July 2025) [Track version]

The ICH M7 Q&A document on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk”  reached Step 2b of the ICH Process on 29 June 2020 and now enters the consultation period.

Following the adoption of the ICH S5(R3) Guideline on Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals, a Step 4 Introductory Training Presentation has been developed by the S5(R3) Expert Working Group in February 2020.

The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.3 reached Step 4 of the ICH process in May 2020.

The International Council for Harmonisation (ICH) met virtually on 27 May, in place of the face-to-face meetings that were to take place in Vancouver, Canada.

Further to ICH’s commitment for stakeholder engagement with academic clinical researchers and patient representatives...

With ICH commemorating its 30th Anniversary in 2020, ICH is pleased to release a video in which ICH Members and Observers look back at ICH’s evolution...

The ICH S11 Guideline on Nonclinical Safety Testing in Support of Development of Pediatric Medicine reached Step 4 of the ICH Process in April 2020.

Bupropion NL/H/PSUFU/00000461/201812 Date of publication: 06/04/2020 PSUSA/00000461/201812 Date of publication: 17/12/2020