ICH E6(R3) Annex 2 comes into effect
ICHGuideline effective
High impact in 62 days
The GCP Annex 2 (decentralised, pragmatic and real-world-data elements of clinical trials) applies in the EU. Sponsors and CROs should update SOPs and trial oversight plans.
Add to Google Calendar Subscribe to all dates (iCal)
Get the outcome, not just the date
VigiEye subscribers get related guidance and regulatory changes summarised by AI, filtered to their products and markets. The free weekly email lists this date when it is two weeks out.
Free weekly "EU regulatory week ahead" email. Or start monitoring.
Related upcoming dates
Dates are taken from the official source above. Agencies occasionally reschedule; confirm on the source before acting.