{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T19:03:11Z","timestamp":1773082991133,"version":"3.50.1"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2025,6,20]],"date-time":"2025-06-20T00:00:00Z","timestamp":1750377600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,6,20]],"date-time":"2025-06-20T00:00:00Z","timestamp":1750377600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"None","award":["N\/a"],"award-info":[{"award-number":["N\/a"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:p>Pharmaceutical companies are required to provide Risk Management Plans (RMPs) to support the marketing authorisation of medicines. These RMPs contain information on efficacy and safety, outline risks or gaps in information, and detail commitments for post-authorisation pharmacovigilance (PV) studies. These plans aim to enhance understanding of a drug\u2019s benefit-risk profile and information on risk mitigation and labelling strategies to ensure end-users are aware of the risks that are associated with the product. Per defined health authorities trigger, RMPs are updated with new data such as post-authorisation data and expanded product labels (new indications), leading to multiple versions. When specific risks require additional mitigation beyond product labelling, additional risk minimisation materials (aRMMs) may be applied to educate healthcare professionals (HCPs) and patients. In some cases, more stringent controls on drug use may be necessary. In all cases, these risk management commitments must be implemented in applicable countries where the medicine is marketed following local regulatory requirements. Implementing aRMMs necessitates the distribution of core or EU RMPs and aRMMs to local affiliates for localisation, approval by local health authorities, dissemination, and subsequent collection of effectiveness metrics. Managing multiple versions of core and local RMPs, aRMMs, and associated activities becomes a vital data management issue, requiring efficient tracking of the status of each document and locally agreed activities. This article explores developing and deploying a database-driven RMP and aRMM tracking system. It covers the determination of system requirements, the delivery of the system, and the assessment of its impact on the organisation.<\/jats:p>","DOI":"10.1007\/s43441-025-00825-8","type":"journal-article","created":{"date-parts":[[2025,6,20]],"date-time":"2025-06-20T13:44:22Z","timestamp":1750427062000},"page":"901-908","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Tracking a Medicine\u2019s Regulatory Risk Management Commitments Provides Better Transparency and Oversight"],"prefix":"10.1007","volume":"59","author":[{"given":"Simon","family":"Ingate","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kate","family":"Bendall","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Long","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Fetterman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie","family":"Liles-Burden","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmit","family":"Strauss","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,6,20]]},"reference":[{"key":"825_CR1","unstructured":"European Commission. Directive 2010\/84\/EU of the European parliament and of the council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001\/83\/EC on the Community code relating to medicinal products for human use. https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32010L0084%26;qid=1672928232146%26;from=EN Retrieved 13th February 2025."},{"key":"825_CR2","unstructured":"European Commission: Regulation (EC). No. 726\/2004 of the European Parliament and council of the 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32004R0726&qid=1672929502538&from=EN Retrieved 13th February 2025."},{"key":"825_CR3","unstructured":"European Commission: Regulation (EU) No 1235\/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December. 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726\/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394\/2007 on advanced therapy medicinal products. https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32010R1235 Retrieved 13th February 2025."},{"key":"825_CR4","unstructured":"EMA. Guideline of good pharmacovigilance practices (GVP)\u2013 Module VI\u2013 Collection, management, and submission of reports of suspected adverse reactions to medicinal products (Rev2) 22\/11\/2017 https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf Accessed 13th February 2025."},{"key":"825_CR5","unstructured":"EMA: Guideline on good pharmacovigilance practices (GVP). Module VIII\u2013 Post Authorisation safety studies (Rev 3) 13\/10\/2017. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-good-pharmacovigilance-practices-gvp-module-viii-post-authorisation-safety-studies-rev-3_en.pdf Accessed 13th February 2025."},{"key":"825_CR6","unstructured":"EMA: Guideline on good pharmacovigilance practices (GVP). Module VIII Addendum I\u2013 Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 3) 23\/06\/2020. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-good-pharmacovigilance-practices-gvp-module-viii-addendum-i-requirements-recommendations_en-1.pdf Accessed February 8th, 2025."},{"key":"825_CR7","unstructured":"EMA. How to prepare and review a summary of product characteristics (Training, Guidance, Guidelines and SmPC recommendations) 21\/01\/2013. https:\/\/www.ema.europa.eu\/en\/human-regulatory\/marketing-authorisation\/product-information\/how-prepare-review-summary-product-characteristics#scientific-guidelines-with-smpc-recommendations-section Accessed 6th August 2024."},{"key":"825_CR8","unstructured":"EMA: Guideline on good pharmacovigilance practices (GVP). Module XVI - Risk minimisation measures (Rev 3). https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/guideline-good-pharmacovigilance-practices-gvp-module-xvi-risk-minimisation-measures-rev-3_en.pdf Accessed 6th August 2024."},{"key":"825_CR9","unstructured":"Guideline on good pharmacovigilance practices (GVP). Module XVI Addendum II\u2013 Methods for evaluating effectiveness of risk minimisation measures. ADD II-03 GVP Module XVI Addendum II - Evaluation - Final published. Accessed 6th August 2024."},{"key":"825_CR10","unstructured":"FDA: Format and Content of a REMS Document; Guidance for Industry. (Jan 2023),. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/format-and-content-rems-document-guidance-industry Retrieved February 12th, 2025."},{"issue":"8","key":"825_CR11","doi-asserted-by":"publisher","first-page":"896","DOI":"10.1002\/pds.3305","volume":"12","author":"L Prieto","year":"2012","unstructured":"Prieto L, Sponer A, Hidalgo-Simon A, Rubino A, Kurz X, Arlett P. Evaluation of the effectiveness or risk minimisation measures. Pharmacoepidemiol Drug Saf. 2012;12(8):896\u20139.","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"825_CR12","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1007\/s40264-013-0126-7","volume":"37","author":"AK Banerjee","year":"2014","unstructured":"Banerjee AK, Zomerdijk IM, Wooder S, Ingate S, Mayall SJ. Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation. Drug Saf. 2014;37:33\u201342.","journal-title":"Drug Saf"},{"key":"825_CR13","unstructured":"EMA: Guideline on good pharmacovigilance practices (GVP). Module VII\u2013 Periodic safety update report 13\/12\/2013. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-good-pharmacovigilance-practices-gvp-module-vii-periodic-safety-update-report_en.pdf Accessed 13th February 2025."},{"key":"825_CR14","unstructured":"FDA: E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) Guidance for Industry Rev 1. July 2016, https:\/\/www.fda.gov\/media\/77846\/download Accessed 13th February 2025."},{"key":"825_CR15","unstructured":"Orbit by Feith Systems. https:\/\/www.workinorbit.com\/rmp-rems\/ Accessed 13th February 2025."},{"issue":"9","key":"825_CR16","doi-asserted-by":"publisher","first-page":"1322","DOI":"10.2105\/AJPH.89.9.1322","volume":"89","author":"RE Glasgow","year":"1999","unstructured":"Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322\u20137.","journal-title":"Am J Public Health"},{"issue":"6","key":"825_CR17","doi-asserted-by":"publisher","first-page":"e38","DOI":"10.2105\/AJPH.2013.301299","volume":"103","author":"B Gaglio","year":"2013","unstructured":"Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. 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