Public Disclosure Guidances and Portals
Review these pages regularly to stay updated on regional guidance on public disclosure of clinical data, including clinical study reports (CSRs).
European Union
Individual study-level documents
Clinical trials in the EU including the CTIS portal and guidances:
EMA Clinical Trials Information System (CTIS)
Clinical Trials Information System (CTIS): training and support | European Medicines Agency (EMA)
Marketing Authorisation Applications (MAAs)
Clinical Data Publication page including EMA Policy 0070 and guidances in support of marketing authorisation applications (MAAs).
Clinical data website for publicly disclosed clinical data supporting MAAs.
Global Regulatory Portals
Health Canada (HC)
Guidance document on public release of clinical information.
Food and Drug Administration (United States FDA)
News and Updates | ClinicalTrials.gov
ClinicalTrials.gov portal.
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