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).