The ICH M9 Guideline and Q&As on Biopharmaceutics Classification System (BCS)-based biowaivers reached Step 4 of the ICH Process

The ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes reached Step 4 of the ICH Process

The ICH E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses reached Step 4 of the ICH Process

The International Council for Harmonisation (ICH) met in Singapore from 16 – 20 November 2019, bringing together over 450 participants from ICH’s sixteen Members and thirty-two Observers.

Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus.

In October 2018, further to a discrepancy raised regarding the Permissible Daily Exposure (PDE) for ethyleneglycol, an error correction procedure was launched...

Cover letter template for renewals (July 2025) [Track version]

CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 (October 2025)

The ICH E17 Guideline on General Principles for Planning and Design of Multi-Regional Clinical Trials was finalised under Step 4 in November 2017. This Guideline provides guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT).

ICH is announcing a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials.” The purpose of the public meeting is to provide information and solicit input from a broad range of non-ICH Member/Observer stakeholders on the draft revised E8(R1) Guideline “General Considerations for Clinical Trials.”