Showing XXX results across 3 categories.
The ICH M13B draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver reached Step 2b of the ICH Process on 13 March 2025 and entered the public consultation period.
The ICH M11 updated version of the Technical Specification document, which incorporates comments received during the first public consultation, reached Step 2b of the ICH process in March 2025 and now enters the second round of public consultation.
Following the adoption of the E6(R3) Guideline on 6 January 2025, a Step 4 Introductory Training Presentation has been developed by the E6(R3) Expert Working Group.
The ICH E6(R3) “Good Clinical Practice” Guideline reached Step 4 of the ICH Process on 6 January 2025.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) is very pleased to announce the appointment of Géraldine Lissalde-Bonnet as Secretary General of the ICH Secretariat based in Geneva, Switzerland.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) is very pleased to announce the appointment of Géraldine Lissalde-Bonnet as Secretary General of the ICH Secretariat based in Geneva, Switzerland.
The ICH Secretariat is pleased to announce the publication of the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers (R5). The ICH Assembly approved this updated Q9(R1) Annex 1 on 30 October 2024.
The ICH M15 draft Guideline on General Principles for Model-Informed Drug Development reached Step 2b of the ICH Process on 6 November 2024 and entered the public consultation period.