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 •  November 30, 2017

ICH decision on multi-regional clinical trials aims to benefit public health The International Council for Harmonisation (ICH) met in Geneva, Switzerland on 11 to 16 November 2017. Among other decisions, the ICH Assembly approved the Health Sciences Authority, Singapore (HSA), as a new Regulatory Member. The Assembly also approved the Instituto...

Newsroom

 •  November 30, 2017

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Telephone: +41 (22) 338 32 06 - admin@ich.org, http://www.ich.org ICH Press Release Geneva, Switzerland, November 2017 ICH decision on multi-regional clinical trials aims to benefit public health The International Council for Harmonisation (ICH) met...

Newsroom

 •  November 30, 2017

The International Council for Harmonisation (ICH) met in Geneva, Switzerland on 11 to 16 November 2017. Among other decisions, the ICH Assembly approved the Health Sciences Authority, Singapore (HSA), as a new Regulatory Member. The Assembly also approved the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia (INVIMA), and the...

Newsroom

 •  October 13, 2017

The ICH revised S5(R3) draft Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 2b of the ICH Process in August 2017 and now enters the consultation period. A training presentation has also been developed by the Expert Working Group.

Newsroom

 •  September 28, 2017

At the Osaka 2016 meeting, the ICH Management Committee endorsed a Pilot Programme for 2017 in which the ICH Training Subcommittee would partner with a small group of training providers to organise and deliver high quality programmes based upon the scientific and regulatory principles outlined in ICH Guidelines. The Subcommittee has identified...

Newsroom

 •  September 28, 2017

In May/June 2017, the ICH Assembly and Management Committee met in Montreal, Canada, for their biannual meeting. Main decisions taken at the ICH Assembly meeting are reflected in a report including the key progress made at this meeting by each technical working group, including expected timeframes for reaching Step 2b / Step 4 of the ICH process....

Newsroom

 •  September 6, 2017

The ICH Q11 Q&A reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5). These Q&As are intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing...

Newsroom

 •  September 4, 2017

The ICH E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses reached Step 2b of the ICH Process in August 2017 and now enters the consultation period. The ICH E9(R1) Addendum promotes harmonised standards on the choice of estimand in clinical trials and describes an agreed framework for planning, conducting...

Newsroom

 •  August 14, 2017

At the Osaka 2016 meeting, the ICH Management Committee endorsed a Pilot Programme for 2017 in which the ICH Training Subcommittee would partner with a small group of training providers to organise and deliver high quality programmes based upon the scientific and regulatory principles outlined in ICH Guidelines. The Subcommittee has identified...

Newsroom

 •  July 26, 2017

In November 2016, the ICH endorsed a new topic on Optimisation of safety data collection. This guideline will provide a harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented. The E19 Concept...