Plan for the Implementation of Artificial Intelligence to Direct its Application in Medicine Regulation EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI ...
What is eCTD 4.0? The Evolution and Advantages of eCTD 4.0 in Global Regulatory Submissions Introduction: The Electronic Common Technical Document (eCTD) has become the standard format for submitting regulatory information to drug regulatory agencies globally. The release of eCTD 4.0 in 2022 marked...