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

Member: Mylene FerrierAlternate: Antoine Treff Health AgencyAllée MarconiVilla LouvignyL-2120 LuxembourgLUXEMBOURG

The E2B(R3) User Guide v1.1 is available for download in the Implementation Package version 1.08 on the ESTRI webpage.

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.