Tracking a Medicine's Regulatory Risk Management Commitments Provides Better Transparency and Oversight.
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...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 59; no. 5; pp. 901 - 909 |
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| Autores principales: | , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Sep2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=188049096&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 188049096 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: Sep2025 vid: 59 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 188049096 186044098 188049096 188049096 10.1007/s43441-025-00825-8 188049096 ppf: 901 ppct: 8 formats: tig: atl: Tracking a Medicine's Regulatory Risk Management Commitments Provides Better Transparency and Oversight. aug: au: Ingate, Simon Bendall, Kate Long, Christopher Fetterman, Kevin Liles-Burden, Marie Strauss, Carmit affil: Axian Consulting Limited, The Bradfield Centre, 184 Cambridge Science Park, CB2 0GA, Cambridge, UK sug: subj: Pharmaceutical Companies Administration Risk Management Government Regulations Organizational Compliance Commitment Pharmacovigilance Methods Human Drug Efficacy Patient Safety Implementation Science Drug Labeling Quality Improvement Methods Interviews Questionnaires Access to Information ab: 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's 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. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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