Objective: To assess the impact of changing European RMP regulations and the growing knowledge regarding benefit-risk of approved products on the lifecycle evolution of EU-RMP safety concerns.
Method: A retrospective study based on the review of 64 EU-RMPs dated between January 2006 to October 2020 for seven medicinal products for which Boehringer Ingelheim holds the Marketing Authorisation in the EU. Data on the rationale behind changes (i.e., addition, reclassification, removal) to the presentation of safety concerns in the EU-RMPs were collected and analysed.
Results: The EU-RMPs included a total of 197 unique safety concerns (including 70 IIRs, 78 IPRs, and 49 MI Topics) of which 129 were removed and 19 were reclassified during the observation period. The implementation of the Guidelines on Good Pharmacovigilance Practices (GVP) Module V in 2012 and the GVP Module V Rev. 2 in 2017 resulted in a significant decrease in the number of safety concerns for five of the seven medicinal products included in this study. Clinical trial data, non-clinical data and routine post-marketing data were the most common sources that influenced the safety concern dynamics (i.e., addition, reclassification, removal). Results from dedicated post-authorisation studies lead to the removal of 21 important risks and missing information topics. Interestingly, many safety concerns were related to pharmacological class effect (n=55) and/or target population characteristics (n=37), and the majority of these were added in response to feedback from health authorities during the review of the market authorisation applications. Furthermore, 49% of the risk removals were prompted by HA, while 51% of the removals were proactively initiated by Boehringer Ingelheim.
Conclusions:
In summary, this study shows how diverse sources of data, including non-clinical data, clinical trial data, post-marketing experience, familiarity with the class effect, contribute to the increasing knowledge of the safety profile and subsequently to the presentation of risks in EU-RMPs. Additionally, our data show how revised pharmacovigilance regulations have influenced the RMPs through encouragement to move towards an evidence-based evaluation of risks, and to continuously re-evaluate safety concerns based on the growing understanding of the benefit risk profile of the product. Moreover, this exercise highlighted the importance of close collaboration between regulators and industry to facilitate exchange of learnings and to take full advantage of all available sources of data throughout the product’s lifecycle. On this basis, we postulate that strong and harmonized regulatory guidelines covering the product lifecycle, along with continuous cooperation between stakeholders are important for ensuring a fit-for-purpose proactive risks management and thus ultimately for protecting patient safety worldwide.

Impact of changing regulations and the dynamic nature of risk management plans on the lifecycle of safety concerns

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Pharmacovigilance Strategies Workshop

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