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Regulatory News | 14 April 2017 | By Michael Mezher
The European Medicines Agency (EMA) on Wednesday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect last fall.
The policy, known as Policy 0070, is part of a push towards greater clinical trial transparency by EMA through the publication of clinical data submitted as part of marketing authorization applications to be published in an online database, regardless of whether the product is ultimately authorized, rejected or withdrawn.
The newly revised guidance updates an earlier revision released in December with a handful of major clarifications, as well as some minor editorial.
While EMA says that in general, all clinical reports submitted as part of a marketing authorization application are subject to publication, the agency clarifies that only some reports that are cross-referenced in an application are subject to publication.
"All clinical study reports cross-referred to within a pediatric extension or modification of indication application submitted in the context of regulatory procedures not falling within the scope of Policy 0070 will be subject to publication. Where clinical study reports are cross-referred to within extension or modification of indication and line extension applications other than pediatric, only the pivotal clinical study reports submitted will be subject to publication," EMA writes.
EMA also clarifies that it is acceptable to remove individual patient data from the section on "abnormal laboratory value listing" from clinical studies reports before publication, but that individual patient data in other sections of the clinical study reports should be anonymized and included.
Additionally, EMA has added a validation checklist for sponsors to follow when preparing their redaction proposal document, as well as a template for abbreviated anonymization reports that can be used for applications that do not contain patient identifiers.
According to EMA, the validation checklist is not a requirement for submission, but can be used to help sponsors and the agency identify validation issues earlier in the submission process.
Guidance, Summary of Changes