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The International Council for Harmonisation (ICH) met in Lisbon, Portugal, 11-16 June 2016, bringing together regulators and industry from around the world.
ICH increases its global reach, moves forward on global drug development.
A Question and Answer (Q&A) document on Membership and Observership can now be found on the ICH website. The Q&A document aims to address questions of potential applicants interested in ICH Membership and Observership.
The Questions and Answers Document of the ICH S3A Guideline on Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure reached Step 2b of the ICH Process in May 2016 and now enters the consultation period (Step 3).
In April 2016, further to the update of the Regulatory Notice Document (RND) in January 2016, the S1 Expert Working Group has completed a Prospective Evaluation Period Status Report.
The Q3D Training Modules 0-7 (Module 0: Overview; Modules 1-7 on key safety and quality topics) can now be found on the ICH website.
On 6 April 2016, the Drug Information Association (DIA) in collaboration with the European Commission (EC) and the European Medicines Agency (EMA) are organising an “Information Day on ICH”.
ICH is pleased to welcome the Therapeutic Goods Administration (TGA) of Australia as its newest Observer.