Recentes

• 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
• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations