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'Historical Moment' As Global Generics Body Gets Seat On ICH Management Committee

Executive Summary

The move recognizes the expertise that generic and biosimilar drug developers can bring to the scientific discussions at the International Council on Harmonisation. 

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The ICH has now largely finished implementing its structural and organizational reforms by adding new regulatory and industry members to the organization. The reform process aims to increase ICH's international outreach and turn it into a “truly global initiative.”

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The international generics drug industry, represented by the International Generic and Biosimilar Medicines Association (IGBA), has formally joined the International Council for Harmonisation as an assembly member, following months of lobbying for a meaningful position at the ICH1.

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The International Conference of Harmonisation has at last finalized its organizational reforms that are expected to encourage the group's expansion beyond its current membership of regulators from five regions (Canada, the EU, Japan, Switzerland and the US) and three research-based pharmaceutical industry associations (from the EU, Japan and the US)1.

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