Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect.
Policy 0070 External Guidance Update – Major Changes
Several major changes are noted in this “Summary of Changes” document, including:
- Clarifications have been added around what is required of withdrawn applications when the application has been or will be re-submitted. Sponsors may not request a delay in publication under Policy 0070, however two clinical packages for publication are required; one for the withdrawn application and one for the re-submitted application.
- Sponsors may also now delay submitting trials where the main period/phase is still on-going at the time of publication. By providing a statement committing to publish once completed, sponsors may now wait until the last subject completes the study.
- Other major changes include:
- a timetable of the main steps in the process.
- additional wording around the review and revision of anonymisation reports.
- helpful submission validation checklists.
Policy 0070 External Guidance Update – Minor Changes
Minor changes are editorial in nature and provide further clarification around the labeling and removal of out of scope pages, which has been a point of confusion through each revision of the guidance document. Pages that are out of scope may be removed from the proposal document package or they may remain if they have a watermark or overlay text indicating they will be removed in the final document package, which is something Synchrogenix’s ClinGenuity Redaction Management Service (CRMS) has always done.
All in all, no revisions were made around the core implementation of the policy or on the anonymisation of clinical reports.