Format and Content of a REMS Document
![Serialization/Aggregation - Live Online Training](files/eca/userImages/training.img/Z-ECA-Serialization-Live-Online-Training.jpg)
Recommendation
23/24 October 2024
Requirements, Challenges & Solutions
The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products, including biological drugs. Additional and more detailed information is provided in a separate guide that includes a REMS Document Template. If the agency determines that a REMS is necessary (see FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary), one or more REMS elements may be required (e.g., medication guide, patient package insert, communication plan). The FDA may also require elements to assure safe use (ETASU). These elements may include one or any combination of the following requirements:
- Health care providers who prescribe the drug have particular training or experience, or are specially certified,
- Pharmacies, practitioners, or health care settings that dispense the drug are specially certified,
- The drug be dispensed to patients only in certain health care settings (e.g. hospitals) and/or with evidence of safe use conditions (e.g. laboratory test results),
- Patients using the drug be subject to monitoring and/or be enrolled in a registry.
REMS Assessment and Submission
According to the FDA, REMS generally must include a timetable for submission of assessments. The timetable must include an assessment by the dates that are 18 months and 3 years after the REMS is initially approved, and an assessment in the 7th year after the REMS is approved (or at another frequency specified in the REMS). A proposed REMS can be included in the initial submission of an original or supplemental application, or submitted as an amendment to an existing application. All supplemental applications that include a new proposed REMS should be submitted as prior approval supplements (PAS). A proposed REMS submitted after product approval and not associated with an existing supplemental application should be submitted as a new supplemental application.
All approved REMS documents and their approved REMS materials are posted on the FDA’s website. More Information is available in FDA´s Guidance Documents Format and Content of a REMS Document and REMS Document Technical Conformance.
Related GMP News
20.06.2024EMA's Reflection Paper on the Use of Real-World Data in Non-Interventional Studies
13.06.2024How to register a QPPV?
13.06.2024Real-World Evidence Provided by EMA
21.05.2024CHMP confirms Suspension of Marketing Authorizations with Studies of Synapse Labs
21.05.2024How to provide IND Safety Reports to FDA
16.04.2024ICH E2D(R1) Draft Guideline on Post-Approval Safety Data