The ICH E8(R1) draft Guideline on General Considerations for Clinical Studies reached Step 2b of the ICH Process in May 2019 and now enters the consultation period. Additionally, a Step 2 Informational Presentation has also been developed by the Expert Working Group.
The ICH E8(R1) draft Guideline on General Considérations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.
ICH is conducting a Call for Expression of Interest for ICH Training Associates with a view to exploring the possibility of contracting appropriate accredited non-profit training organisations/institutions
The ICH Q3D(R1) Guideline reaches Step 4 of the ICH Process
Publication of the ICH M10 draft Guideline and Presentation
In November 2018, the ICH Management Committee met in Charlotte, NC, USA for their bi-annual meeting.
Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs available now on the ICH website
Version 1.23.1.1 of the 4 electronic Application Forms (eAF) is now available. This release v1.23.1.1 is a bug fix release providing usability improvements and technical defect fixes. This bug fix release does not affect the Data Exchange Standard (DES). This new version (v1.23.1.1) of the forms will fully replace the version 1.23.1.0 after transitional period, [...]
The minutes of the ICH Assembly meeting in Charlotte, NC, USA, in November 2018, available now on the ICH Website
Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between 08:00 (UK time)on Saturday, 15 December and 18:00 (UK time) on Sunday, 16 December 2018. Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF) will be affected [...]