Drug Safety: FDA´s new Draft Guidance Regarding REMS

The U.S. Food and Drug Administration, FDA, published its new draft guidance on Format and Content of a REMS Document on October 11, 2017. The guidance revises the 2009 draft guidance for industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications to:

  • provide updated recommendations on the format and content of a REMS document, and
  • remove information related to REMS assessments and proposed REMS modifications that are being addressed in separate guidance documents.

A REMS is a required risk management strategy that can include one or more elements to ensure that the benefits of a drug outweigh its risks. A REMS document establishes the goals and requirements of the REMS. The guidance provides an overview of the types of information that should be included in a REMS document. Additional and more detailed information is provided in the template appended to the guidance (REMS DOCUMENT TEMPLATE).

The REMS document template has the following five sections:

  • Administrative Information,
  • REMS Goals,
  • REMS Requirements,
  • REMS Assessment Timetable,
  • REMS Materials.

Depending on the REMS requirements, the REMS document will include sections and text, as applicable.

According to the FDA, the guidance and the appended template provide recommendations to applicants on drafting proposed REMS documents and converting an already approved REMS document to a new, standardized format that is clearer, more informative, and supports submission of a REMS document in Structured Product Labeling (SPL) format. The FDA does not expect applicants of an approved product subject to a REMS to submit a proposed REMS modification solely to convert their REMS document to the new format. Changing the REMS document to the new format should be done in conjunction with other REMS modifications.

Additionally, "the guidance does not provide detailed information on the format and content of other documents that are part of a REMS submission, such as the REMS materials or the REMS supporting document. Furthermore, the guidance does not include information on how to design, implement, or evaluate a REMS, and does not address submissions that are unique to shared system REMS", the agency says.

For further clarification whether a REMS is necessary the FDA published the draft guidance "FDA´s Application of Statutory Factors in Determining When a REMS Is Necessary" in September 2016.

In the EU, the GVP-Module V (effective since March 31, 2017) covers the topic risk management. The template for preparation of a Risk Management Plan (RMP) for initial marketing authorization application has recently been revised (Rev 2). Its use for all RMP submissions becomes mandatory as of 31 March 2018.

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