The new European biotech act, announced in Ursula von der Leyen’s political guidelines for 2025, was not included in the Commission work programme published on 11 February, but has recently been announced for early 2026.
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- EMA Updates Guidance on National Pharmacovigilance Contact Person Requirements
- ICH E20 draft guideline on adaptive designs in confirmatory clinical trials
- Critical shortages of medicines. European Court of Auditors’ Special Report
- EDQM publishes new guidelines on the classification of active pharmaceutical substances as regards their supply
- Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR). MEDTECH E-BOOK
- A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
- Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices Version 4 – September 2025
- ICH adopts M14 guideline on observational studies