Guidelines & consultations - VPH

EMA issue new guidelines on scientific advice for clinical trial authorization
- https://www.ema.europa.eu/en/news/improved-scientific-advice-medicines-public-health-threats-including-antimicrobial-resistance
EMA ICH E20 guideline on adaptive designs for clinical trials – Step 2b
- https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e20-guideline-adaptive-designs-clinical-trials-step-2b_en.pdf
EC Public Consultation on the proposal for a revision of Regulation (EU) No 1025/2012, also called the ‘EU Standardisation Regulation’
- Deadline: 17 December 2025
- https://single-market-economy.ec.europa.eu/consultations/public-consultation-proposal-revision[…]on-eu-no-10252012-also-called-eu-standardisation_en
EMA Patient experience data (PED) reflection paper
- Deadline: – Jan 31, 2026
- https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-patient-experience-data_en.pdf

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