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Reference cardRegulations and guidance

When does E6(R3) apply at EU sites, and what is Annex 2?

On the EMA page, the ICH E6(R3) Principles and Annex 1 are effective from 23 July 2025. Annex 2 reached Step 4 with ICH adoption on 3 June 2026 and CHMP adoption on 25 June 2026, and comes into effect on 15 January 2027.

Open the official source
Official sourceEMA: ICH E6 Good clinical practicewww.ema.europa.eu
Checked on October 13, 2026

Next steps

  • Open the Annex 2 document from the same EMA page.
  • See the FDA page for the US version of E6(R3).