This document outlines a brief overview of the main new features in EUDAMED Production v2.12 compared to the previous release
News & Trends
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Recentes
- Considerations for Complying With 21 CFR 211.110 Guidance for Industry
- Final version of its Guideline for Good Clinical Practice E6(R3). Adopted on 6 january 2025
- New EU rules for health technology assessments become effective
- ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions Step 5
- Inter-association joint position paper on Electronic Product Information
- MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
- Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway