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 •  September 6

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

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

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

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...

Newsroom

 •  June 21

The ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5). To complement the harmonised ICH M7 Guideline, an Addendum has been developed to summarise known mutagenic impurities commonly found or used in drug synthesis. The intent of this Addendum is to provide useful information...

Newsroom

 •  June 21

At the ICH meeting in Montreal, Canada, on 27 May to 1 June 2017, the ICH Assembly and ICH Management Committee made some revisions to the Articles of Association, Rules of Procedure and Standard Operating Procedures for Working Groups. Changes made included those aimed at maintaining the efficiency of ICH’s harmonisation activities. The revised...

Newsroom

 •  June 19

The Association begins new work on medicines for children and better clinical trials and China Food and Drug Administration joins ICH. The International Council for Harmonisation (ICH) met in Montreal, Canada on 27 May to 1 June 2017. Among other decisions, the ICH Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory...

Newsroom

 •  June 19

The International Council for Harmonisation (ICH) met in Montreal, Canada on 27 May to 1 June 2017. Among other decisions, the ICH Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, and Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a new Observer. With these new parties, there are now 14 members...

Newsroom

 •  June 12

Montreal, Canada 2017 – The MedDRA Management Board met in Montreal, Canada on 27-28 May 2017. Expansion of MedDRA Use The MedDRA Maintenance and Support Services Organization (MSSO) and the Japanese Maintenance Organization (JMO) reported on the growth of their subscriber bases. The number of subscribing organizations to MedDRA is now over 5,000...

Newsroom

 •  June 12

The ICH MedDRA Management Board met in Montreal, Canada on May 27-28, 2017 and announces its coordination with the WHO Collaborating Centre for International Drug Monitoring...