FDAnews Drug Daily Bulletin

ICH Adopts Update to GCP Guideline; Regional Guidances to Follow

Nov. 23, 2016

The International Council for Harmonisation adopted an update to its good clinical practice guideline, recommending approaches to clinical trial design and management, as well as ensuring patient protection and data integrity. The amendment to its E6 guideline will now be implemented by ICH members through national and regional guidance.

During its meeting in Osaka, Japan, ICH members also agreed to consider renewing the wider package of guidelines that relate to clinical trial design and practices, including guidance on interventional trials and methodologies, as well as the use of real-world evidence and patient registries. The ICH plans to publish a long-term work agenda early next year.

The ICH also decided to begin work on developing a new guideline on safety data, to be called E19, that would set collection requirements for late-stage premarket and post-approval investigations.

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