UMBRA Benefit-risk Framework

Goal/purpose

Enable a systematic approach to benefit-risk decision making

Overview

The Unified Methdologies for Benefit-Risk Assessment (UMBRA) framework provides a structured, transparent approach for evaluating the benefits and risks of medicines during regulatory assessment. It guides assessors through the key steps of defining the decision context, characterising evidence, weighing uncertainties, and articulating the rationale behind final decisions. The accompanying template supports clear, consistent documentation and helps ensure that benefit–risk considerations are communicated in a logical and reproducible manner. Regulatory agencies use the UMBRA framework and template to strengthen the quality, transparency, and predictability of their product evaluations.

Who UMBRA is for

Any regulatory agency, regardless of size or maturity, can use the UMBRA framework and template.

How UMBRA works

The UMBRA framework is divided into eight steps to frame the decision, identify the benefits and the risks, assess those benefits and risks, and interpret them to make recommendations (see graphic, right).

The UMBRA template follows this framework and is completed by agency assessors for specific products. The completed templates can inform internal and external discussions on benefit risk, including interactions with companies, and with other agencies in the case of risk-based reliance reviews and work sharing. They can also serve as the basis for public assessment reports.

Practical use cases

The UMBRA framework and template have been used by regulators in Asia, Africa, Australia, North and South America, Europe, and the Middle East in various ways:

• Retrospective and prospective case studies on the benefit-risk assessment of medicinal products
• Modifying clinical assessment templates
• Ensuring alignment of processes compared to other agencies
• Facilitating risk-based reliance reviews and work sharing
• As a reviewer training tool to support structured systematic reviews.

WHO Global Benchmarking Tool (GBT) indicators supported by UMBRA

• GBT RS09.03: Information on decisions related to regulatory activities is available to the public
• GBT RS03.04: Reliance on the decisions of other mature NRAs through documented policy, procedures, and/or mechanisms must be formalised
• GBT MA05.03: NRAs are required to publish the summary technical evaluation reports for approved applications of marketing authorisation in the public domain