REMS (Risk Evaluation and Mitigation Strategies) and RMPs (Risk Management Plans) provide positive guidance for identifying, monitoring and minimizing the risk of patient safety. They do differ on elements such as the monitoring of the implementation of risk minimization actions and the reporting time requirements.
The EU RMP is a more comprehensive, more extensive safety package that the sponsor is obligated to follow throughout the lifecycle of all new drugs or biologics. The main components of an EU RMP are risk assessment, pharmacovigilance activities and risk minimization activities (which are mainly associated with the SmPC and PL).
In the EU, an RMP is required for a new marketing application. It is provided to RAs as one of the documents to be completed before the Marketing Authorization Application (MAA) is submitted, because it can only be finalized when the summary of product characteristics is final. The aim of the RMP is to describe the safety profile of the drug, i.e., the important identified potential risks and missing information.
RMP management is also an ongoing activity, involving updating the RMP and implementing or responding to comments from Regulatory assessors.
- Preparation of RMP, review and maintenance.
- Develop strategic and tactical plans to characterize and quantify safety concerns and minimize risks to patients
- Provide support throughout the submission process
- Customize risk management strategies to local requirements
- Implementation of additional pharmacovigilance activities and risk minimization measures including Post-Authorization Safety Studies (PASS) such as observational studies and registries, creation of targeted questionnaires, and designing and implementing educational materials for risk minimization.
- Design and implement interventions or studies that align with risk management and data collection objectives and effectively implement these actions or studies in the post-marketing world
- Revise and update the risk management document, if warranted, as an outcome of the effectiveness evaluation
The US REMS concerns itself with communication of risk, which consists of components such as Medication Guide, Communication Plan, Elements to Assure Safe Use, Implementation System and Timetable for Submission of Assessments. The US REMS is compulsory only for some medicines.
REMS programs can be designed for a single drug or a class of drugs. Each REMS has specific safety measure unique to the safety risks associated with a particular drug or class of drugs.
- Evaluation of the requirement for REMS, if the request received from the FDA
- Preparation of key elements of REMS like Medication Guide or Patient Package Insert, Communication Plan, Elements to Assure Safe Use (ETASU) and Implementation System
- Inclusion of the timetable for assessment of the REMS
- Preparation of the required documents as per the REMS program meetings
- Play a key role in preparation/compilation of REMS report as per the REMS program meetings
- Sharing the information regarding REMS program meetings as per the agreed time intervals as and when required
- Handling the queries/issues related to REMS data as per the REMs program meetings
- Provide continuous support, until REMS approval
- Providing further assistance on updates/feedback shared by the FDA
- Single Shared System (SSS)
- Single REMS document, REMS materials (except MGs) and supporting documents
- Shared database and infrastructure