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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.
The coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue.
The ICH Q3C(R8) draft Guideline on Impurities: Guideline for Residual Solvents, revised to include the Permitted Daily Exposure (PDE) levels for 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether and Tertiary Butyl Alcohol, reached Step 2b of the ICH Process in March 2020.
The ICH biannual meeting, scheduled to be held in Vancouver in May 2020, is cancelled.
The ICH M9 Guideline on Biopharmaceutics Classification System-based Biowaivers reached Step 4 of the ICH Process in November 2019.
The ICH S5(R3) Guideline on Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 4 of the ICH Process in February 2020.
On Thursday, 31 October 2019, as part of the GCP renovation plan, ICH held a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials” hosted by FDA, United States at their headquarters in Silver Spring, MD, USA.