New Risk Management Plan (RMP) template becomes mandatory
The new Risk Management Plan format – a major improvement for generic and well-established products
By Ea Dige
On 30 March 2017 EMA published Revision 2 of the guidance on the format for RMPs with major revisions both to guidance (GVP module V) and template. Several sections of the RMP, which previously required considerable resources to prepare, have been defined in a new way, with less repetition and duplication.
The new format supports a better overview in case an RMP needs to be updated due to new safety findings during the lifecycle of the product.
Epidemiology of the target indications and target population (Part II-Module SI)
Post-authorization experience (Part II-Module SV)
Additional EU requirements for the safety specification (Part II-Module SVI)
RMP modules that are still applicable:
Identified and potential risks (Part II-Module SVII): The proposed safety concerns must be justified based on evidence from published scientific literature. Listing none of the safety concerns from literature is also possible when this is justified.
Summary of safety concerns (Part II-Module SVIII): It is now expected that the safety specification is the same as that of the RMP for the reference medicinal product, if available. This means that Safety concerns do not ‘have to’ be evaluated and presented based on considerations from the applicant.
If a ‘reference risk information’ is not available, then all relevant information (e.g. public assessment documents and literature) should be included when preparing the Summary, in the same way as previously required.
Get guidance for preparation and evaluation of your Risk Management Plans
PharmAdvice specializes in supporting customers with Risk Management Plans for new applications as well as revisions, making sure that current good pharmacovigilance practices are followed.
For questions and support in regards to Safety Variations, please contact Ea Dige.
For an initial talk, please feel free to contact Ea directly at: +45 4450 3203, or via
Ea DigePharmacovigilance Manager and QPPV, MD
Ea has more than 20 years of experience from the international pharmaceutical industry with special focus on post-marketing safety surveillance, surveillance of safety during clinical trials and previous experience as Medical Assessor at the Danish Health and Medicines Authority.