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ICH E6(R3): Annex 2 on decentralised and pragmatic trials takes effect in January 2027
The updated Good Clinical Practice guideline has applied in the EU since 23 July 2025. Its Annex 2, on decentralised and pragmatic trials and real-world data, follows on 15 January 2027.
CRO · 6 November 2026
EU HTA Regulation: joint clinical assessments are under way
Since 12 January 2025 new cancer medicines and advanced therapies go through a joint EU clinical assessment. Orphan medicines follow in 2028 and the full scope of the Regulation in 2030.
Regulatory Affairs · 3 November 2026
EU Clinical Trials Regulation: the transition to CTIS is complete
Since 31 January 2025 every clinical trial in the EU runs under the Clinical Trials Regulation, with the Clinical Trials Information System as the single entry point.
CRO · 9 October 2024