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A Risk Management Plan (RMP), required in the European Union, is a description of a medicine’s safety profile; how its risks will be prevented or minimized in patients; plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine; measuring the effectiveness of risk-minimization measures. Its purpose is to document the risk management system considered necessary to identify, characterize, and minimize the medicinal product’s important risks.
The RMP is written according to a modular structure and contains the product overview, the safety specification, the pharmacovigilance plan, the plans for post-authorization efficacy studies, the risk minimization plan, and the summary of the RMP (ie, the precursor of the publicly available RMP summary).
The RMP is submitted to EMA (as the EU-RMP) or to other local regulatory authorities if required (as core RMP or core RMP addendum). After the initial submission with the marketing authorization application, the RMP is updated as needed: upon request of health authorities or whenever the risk management system is modified.
Writing the RMP is a team effort involving many functions. It is developed based on several source documents, including but not limited to the nonclinical and clinical overviews and summaries and the PSUR/PBRER (for marketed products). It should provide an integrated overview/discussion focusing on the most important risks that have been identified or are anticipated based on preclinical, clinical and post-marketing data presented in other modules of the Common Technical Document.
The Emtex Medical Writers can help you with the document development process (eg, writing sections and coordinating the review and consolidation of comments). Furthermore, the Emtex Medical Writer can play a critical role in ensuring that all contributions from the involved functions are provided and reviewed in a timely manner and that the data presented is in line with the information contained in other submission documents (eg, clinical overview, clinical summaries).
FAQ: Risk Management Plan (RMP)
What is a Risk Management Plan (RMP)?
An RMP provides an overview of a medicine's safety profile and describes how important risks will be identified, monitored, prevented, or minimized. It also outlines planned studies and activities to further evaluate the medicine's safety and efficacy and to measure the effectiveness of the risk minimization measures.
When is an RMP needed?
An RMP needs to be submitted to EMA (as EU-RMP) or to other local regulatory authorities (as core RMP) as part of a marketing authorization application. After initial submission, the RMP should be updated whenever requested by health authorities or whenever the risk management system is modified.
Why is it challenging to prepare an RMP ?
Preparing an RMP can be challenging because it requires the integration of multidisciplinary input and complex safety information into a consistent risk management strategy.
How can Emtex Life Science support the preparation of the RMP?
Emtex Life Science can support the preparation of RMPs by authoring sections, coordinating input from multiple contributors, managing timelines, and helping ensure consistency across related documents.
Why is professional medical writing support valuable for the RMP?
Professional medical writers help combine multidisciplinary input into a coherent document that clearly communicates the product's key risks and the measures in place to monitor and minimize them.