EUDRAC attended the recent EMA/DIA meeting where the philosophy and key points of the change to the RMP template were explained and discussed.

Impact on marketing authorisation holders

The use of RMP Rev.2 for all RMP submissions becomes mandatory for all RMP submissions as of 31 March 2018. Therefore marketing authorisation holders who require an update to their RMPs, e.g. via variation, will be required to update the RMP to Rev.2. Transitioning an RMP to Rev.2 is not a trivial process. Although many of the sections in the RMP Rev.1 mirror those in RMP Rev.2, there are several sections which require additional information and re-writing.

RMP Rev. 2 philosophy

The updates to RMP Rev. 2 are substantial and many of the changes have been received positively by the industry. One of which is the reduction / removal of duplicated information; this has removed much of the administrative burden of maintaining an RMP. Other major updates include:

  • A greater separation between the RMP and the PSUR with a focus on not duplicating information within the documents
  • The RMP Rev. 2 attempts to have a much narrower scope and highlights just the key risk (i.e. those which affect the risk/benefit of the product)
    • RMP unresolved issues should reduce over time with the attempt to have no or very few unresolved issues in the RMP.
    • Rule-of-thumb is to include safety concerns in the RMP which the company is actively minimising the risk for or assessing to see if the safety concern is low risk.
  • Removal of the template for generics and combine the information into one template
  • Version controlling is to be more controlled (however this is not mandatory)
  • Section SVII.1 will lock after approval of initial RMP and never change in subsequent RMP revisions.
  • A streamlined process for the RMP summary. The RMP summary will be approved at time of RMP approval and will be uploaded to the EMA website as a standalone document without further EMA review.

Please see a link to an overview training presentation of the main changes to RMP Rev. 2.

What EUDRAC can do to help?

EUDRAC has transitioned several RMPs to the new RMP Rev.2 template and will continue to write and review RMPs into their new (and improved) format. For more information or support in writing or reviewing RMPs please contact us here.