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The International Council for Harmonisation (ICH) met in Montreal, Canada on 27 May to 1 June 2017.
The Association begins new work on medicines for children and better clinical trials and China Food and Drug Administration joins ICH.
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.
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 in 103 countries.
The ICH Management Committee identified the Expert & Implementation Working Groups to meet at the upcoming ICH meeting to take place in Montreal.
The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances, regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period.
The ICH E11(R1) draft Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process and is currently under public consultation.
ICH E6(R1) on Good Clinical Practice (GCP) has been amended to encourage implementation of improved and more efficient approaches to clinical trials design, conduct, oversight, recording and reporting.