The European Medicines Agency (EMA) has outlined the major and minor changes that have been made to the guidance on the agency’s policy on the publication of clinical data for medicinal products for human use. Changes include clarification on publication of data relating to withdrawn applications and a more detailed explanation of the process of publication.
The policy, which is known as ‘Policy 0070’ was adopted by the EMA Management Board on 2nd October 2014, and is made up of two phases. Phase 1 entered into force on 1st January 2015, and relates to the publication of clinical reports. Phase 2, which currently does not have an implementation date, relates to publishing of individual patient data (IPD).
To ensure that Policy 0070 meets its objectives, additional guidance has been published on the procedural aspects that are related to the submission of clinical reports for the purpose of publication, on the anonymisation of clinical reports and on the identification and redaction of commercially confidential information in clinical reports submitted to the EMA.
The new guidance states that “in case of withdrawn applications where there is a confirmed re-submission date or re-submission of the application has already taken place, it is possible to request a delay in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procedure, the Agency will generally consider the postponement of the publication of the clinical data package for the withdrawn marketing application, with the understanding that the clinical data package will be published for the withdrawn product, once there is an outcome of the decision making process for the resubmitted regulatory application.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the applicant is expected to submit two clinical packages for publication under Policy 0070; one package for the withdrawn application and one package for the re-submitted application.”
The updated guidance includes a more explicit explanation of the major steps of the end-to-end process for the publication of clinical reports. Furthermore, the guidance has additional wording on the potential need to submit an updated anoymisation report and/or written responses to the comments broadcast by the EMA on the anonymisation report before the submission of the ‘Final Redacted Document’ package. New wording also highlights the availability of a checklist to assist applicants/Marketing Authorisation Holders (MAHs) with the preparation of the Final Redacted Document package.
To read the guidance on the implementation of the EMA policy on the publication of clinical data for medicinal products for human use, please click here.
To view the summary of changes to the guidance, please click here.