The Evolution of Policy 0070: EMA Clinical Data Publication

The public availability of clinical trial information in on the EU Portal and Database is a key element of the Clinical Trial Regulation (CTReg). While Policy 0070 differs from the CTReg in scope, redacted/anonymised versions of clinical study reports (CSRs) of at least some studies will be published under both rules. Apart from references to Policy 0070, no details are yet available on standards and processes for redacted/anonymised versions of CSRs and other clinical documents to be submitted to the EU Portal under the CTReg framework. This session will focus on the transparency provisions in the CTReg as well as the implementation status of Policy 0070 {backlog, phase II, Technical Anonymisation Group (TAG)} and the status of the Portal used for sharing documents and the technicalities of the process of submitting and accessing documents. The future of the Policy 0070 requirements and process when the CTReg is fully implemented will also be addressed.