The EMA published the FHIR Conceptual Data Model (CDM)
US FDA Adverse Event Reporting System (FAERS) Electronic Submissions
EMA Publishes New Timeline For DADI Project
US FDA Adopts ICH Clinical Trials Guideline with Exclusive Reference to E2B(R3) Standards
CMDh Updates Guidelines to Implement Northern Ireland Protocol (Brexit relevant information)
US FDA announces that DTD version 3.3 will be made mandatory for eCTD submissions
Use of E2B(R3) Becomes Mandatory June 2022 - How to Prepare
EU Clinical Trials Regulation Now in Effect
EMA Updates Technical Guidance for eCTD Submissions in the EU
MHRA updates Guidance for Centrally Authorized Products (CAPs) to UK Marketing Authorization (MAs)
New EU Guidance on Data Submission for Investigational Medicines
Australia readies itself for eCTD only
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