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