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.”
In June 2019, the ICH Assembly met in Amsterdam, the Netherlands for its bi-annual meeting. To ensure transparency in the ICH process, minutes from this meeting are made publicly available so that all stakeholders can be informed on important decisions and real-time progress of the development of ICH Guidelines.
ICH is announcing a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials”, to be held on October 31, 2019 at 08:30 a.m. to 5:00 p.m. ET in Silver Spring, Maryland, USA, with Webcast option available.
The MedDRA Management Committee noted that 1 March 2019 marked the 20th anniversary of the first release of MedDRA. From its beginning, starting with 254 subscribers in 1999, MedDRA has experienced remarkable growth with currently over 5,700 subscribing organisations...