Showing XXX results across 3 categories.
The ICH E21 draft Guideline on “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials” reached Step 2b of the ICH Process in May 2025 and has entered the consultation period.
The Assembly of the International Council for Harmonisation (ICH) met in-person on 13 & 14 May, in Madrid, Spain in parallel with meetings of 11 Working Groups preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
The Assembly of the International Council for Harmonisation (ICH) met in-person on 13 & 14 May, in Madrid, Spain in parallel of meetings of 11 Working Groups preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
The ICH Secretariat is pleased to announce the publication of the ICH Q5A(R2) “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” Guideline training materials.
The ICH Q1 draft Guideline on "Stability Testing of Drug Substances and Drug Products" reached Step 2b of the ICH Process on 11 April 2025 and entered the public consultation period.
As ICH celebrates its 35th anniversary in 2025, DIA proudly honors its extraordinary impact on global health.
The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.9 reached Step 4 of the ICH process in March 2025.
In follow up to the publication of the ICH M11 Updated Technical Specification (TS) in March 2025, the M11 EWG has also prepared a Step 2 informational presentation.