There is no longer an automatic requirement to update RMPs on a fixed-time basis. The Agency and the national competent authorities (NCAs) in EU Member States are now adopting a risk-based approach to RMP updates.
An updated RMP should now be submitted:
- At the request of the Agency or an NCA
- Whenever the risk-management system is modified especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as a result of an important pharmacovigilance or risk-minimisation milestone being reached.
When justified by risk, the competent authority may still specify a date for submission of the next RMP as a condition of the marketing authorisation in exceptional cases.
If the date for the submission of a periodic safety update report (PSUR) and the need to update a RMP coincide, both can be submitted at the same time. There is of course a need to submit a new or updated RMP at the time of MAA or renewal.
Changes to ‘important missing information’
The word ‘important’ has been removed from the phrase ‘important missing information‘ within risk-management documents defining what constitutes a safety concern in an RMP.
Safety concerns are now classified as:
- Important identified risks
- Important potential risks
- Missing information
Previously, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E2E and all EU risk-management documents used the terms ‘important identified risks’, ‘important potential risks’ and’ important missing information’ to define safety concerns in RMPs.
This change was introduced to avoid misunderstanding with regard to Article 12 of Regulation (EC) No 726/2004, which states that a marketing authorisation should be refused if the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of its product.
The concept of a safety concern has not changed; it is still missing information that could be clinically important and that needs to be captured. The only change is the way that this concept is expressed.
All the appropriate guidance documents on the format of RMPs have been updated to reflect this change.
Updates to good-pharmacovigilance-practice (GVP) guideline module V and annex 1 are scheduled for update later in 2013. As part of the continuous improvement exercise, it is likely that there will be further revisions to the RMP formats later in 2013 to reflect the experience over the last year.