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. 2022 Jan 31;36(1):33–46. doi: 10.1007/s40290-021-00414-8

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© The Author(s) 2022

Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

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Fig. 6 — Types of sources that resulted in the inclusion, removal or reclassification of SCs listed in EU-RMP. Data on the types of sources (categories defined in Box 3) influencing the lifecycle evolution of SCs were obtained from EU-RMPs for all seven medicinal (excluding the IIRs for Product B). Multiple types of sources could be associated with the inclusion, removal or reclassification of each unique SC. a The x-axis shows the total number of unique SCs included in the reviewed EU-RMPs at any point in time, and the number of SCs whose inclusion in the EU-RMP was associated with evidence from the specified

source category (y-axis); b The x-axis shows the total number of SCs that were removed from the EU-RMPs during the studied period, and the number of SCs whose removal from the EU-RMP was based on data from the indicated source category (y-axis); c The x-axis shows the total number of reclassified safety concerns, and the number of SCs whose reclassification from IPR to IIR or from MI to IPR in the EU-RMP was based on information from the indicated category (y-axis); d The proportion (%) of reclassified SCs associated with (YES) or not with (NO) Pharmacological Class Effect and/or Target Population characteristics; e shows the proportion (%) of removed SCs triggered by a HA versus initiated by BI; f shows the proportion (%) of SCs associated with Pharmacological Class Effect and/or Target Population Characteristics that was added in response to feedback from regulators during the market authorisation application process. aPV additional pharmacovigilance, BI Boehringer Ingelheim, EU-RMP European Risk Management Plan, GVP Guidelines on Good Pharmacovigilance Practices, HA health authority, IIR important identified risk, IPR important potential risk, MI missing information, PASS Post-authorisation Safety Studies, PV pharmacovigilance, RM risk management, SCs safety concerns