Release of Regulatory Data by EMA may have impact for Journals and Research Synthesis

Final version of policy on release of CSRs of Trials for marketing authorization holders submitted by sponsors published by EMA. The policy will come into effect from 1st Jan 2015.

The policy will allow access to incomplete CSRs at to two levels-Viewer and Researcher level. The viewer level will allow onscreen viewing with simple registration procedure whereas researcher level will be allowed to download and go for OCR searches in the CSR but in other cases will require an identity proof. The access will be prospective which means CSR can be formatted and written for direct web posting after a regulatory decision has been taken and after obtaining access credentials it will not be required to ask everytime that you want a CSR.

The policy will allow easy access to look at the CSRs. For eg if in a journal article it is written that the trial was placebo controlled or double blind etc the case can be checked for its accuracy in the CSR. The Policy doesn’t provide the basis of only releasing some part of CSR and not complete CSR. The policy does not clarify the redaction rules in the CSR and has unclear legal aspects.