The revision updates the previous version released in March, which clarified the agency's expectations for the data required to submit for publishing under the agency's clinical trial transparency rules.
EMA says it has updated the section on the guidance's scope to clarify that "all clinical reports submitted as part of, or cross-referred to within a regulatory application will be subject to publication following the redaction of [commercially confidential information] CCI and [protected personal data] PPD."
For instance, EMA says, that any studies involving an authorized medicine in pediatric populations required under Article 46 of Regulation (EC) No 1901/2006 (known as the Paediatric Regulation) that are referenced in a regulatory procedure to add or modify a drug's indication must be published in the clinical trial database.
The revised guidance also includes a number of other changes and clarifications, including information on how sponsors should handle removing "out of scope" individual patient data from clinical reports, how the agency will handle incomplete redaction proposals, and how sponsors should distinguish between redacted CCI and PPD within their documents.
Alongside the revised guidance, EMA also provided a look into the clinical data publication program's achievements to date.
As of 23 November, the agency has published clinical data for four drugs: Zurampic (lesinurad), Kyprolis (carfilzomib), Armisarte (pemetrexed diacid monohydrate) and Caspofungin Accord (caspofungin acetate).
Since opening up the program's web portal in October, EMA says that 234 academic/non-commercial research users and more than 1,000 general users have registered for the site. In total, the agency says, those users have viewed nearly 4,500 documents and downloaded more than 16,000 documents.
Revised Guidance, Summary of Changes