The ICH biannual meeting, scheduled to be held in Athens in November 2020 is cancelled.

D70 Preliminary AR         D70 Overview AR Template (empty) (May 2022)         Overview AR Template (including instructions) (January 2024)         Quality (January 2017)         Non-clinical (October 2016)         Clinical (January 2017) D100 CMS Comments (April 2023) D105 clock stop (March 2012) Applicant's response template (September 2023) D120 Draft AR         Non-clinical (October 2016)         Clinical (October [...]

In May 2020, the ICH Management Committee and the ICH Assembly both held virtual meetings for their bi-annual meetings.

The ICH M7 Q&A draft document reached Step 2b of the ICH Process in June 2020 and now enters the consultation period. Additionally, a Step 2 Informational Presentation has also been developed by the M7(R2) Maintenance EWG/IWG.

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.

Elvanse (lisdexamfetamine dimesylate)SE/W/0031/pdWS/001End of procedure: 10/03/2020Date of publication: 08/06/2020SE/W/0031/pdWS/002End of procedure: 08/12/2025Date of publication: 10/02/2026

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.