EMA Revises Guidance on Publication of Clinical Trials Policy
Posted 09 November 2018 | By
The European Medicines Agency on Friday offered a look at the major and minor changes made to guidance on the agency’s policy on the publication of clinical data for medicinal products for human use.
The policy, known as “Policy 0070,” was adopted by the EMA Management Board on 2 October 2014 and is composed of two phases. Phase 1 entered into force on 1 January 2015 and pertains to publication of clinical reports while Phase 2, which will be implemented “at a later stage,” pertains to the publishing of individual patient data (IPD).
Further guidance to ensure that Policy 0070 meets its objectives has been published on the procedural aspects related to the submission of clinical reports for the purpose of publication, on the anonymization of clinical reports for the purpose of publication and on the identification and redaction of commercially confidential information in clinical reports submitted to EMA for the purpose of publication.
EMA on Friday released a new document
summarizing the major and minor changes to the guidance. In terms of major changes, the agency notes that there is now more clarification on the publication of withdrawn applications in cases where the application has been resubmitted or has an agreed re-submission date. The new guidance notes:
“However, in case of withdrawn applications where there is a confirmed re-submission date (e.g. CHMP eligibility letter) or resubmission of the application has already taken place, it is possible to request a delay in publication under Policy 0070. In light of the re-submission of the regulatory procedure, the Agency will generally consider the postponement of the publication of the clinical data package for the withdrawn marketing application, with the understanding that the clinical data package will be published for the withdrawn product, once there is an outcome of the decision making process for the resubmitted regulatory application. In such cases, following the conclusion of the re-submitted application, the applicant is expected to submit two clinical packages for publication under Policy 0070; one package for the withdrawn application and one package for the re-submitted application.”
Clarification was also made on the publication of clinical studies where, in exceptional circumstances, the main period/phase of a clinical study is ongoing at the time of publication.
The revised guidance also includes a more explicit explanation of the main steps of the end-to-end process for the publication of clinical reports. The revised guidance also added wording on the potential need to submit an updated anonymization report and/or written responses to the comments transmitted by EMA on the anonymization report before the submission of the “Final Redacted Document” package. New wording in the guidance also flags the availability of a checklist to assist applicants/MAHs with the preparation of the Final Redacted Document package.
Four additional minor changes were also made to the document, including new clarification on the labeling requirements of information considered to be out of scope of phase 1 of Policy 0070.
External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use