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Global Regulatory Acceptance
Working Group

Working Group Overview

The Global Regulatory Acceptance working group was established during the initial Phase IV activities to explore the acceptance of Real-World Evidence by various Regulatory Authorities.  The working group decided to evaluate the current landscape to include review of RWE examples, RWE Regulatory Documents as well as feedback from Regulated Industry about their RWE experiences within one or more Regulatory jurisdictions.

The working group is led by the following Co-Chairs: 

  • Industry: Melanie Raska, Boston Scientific

  • FDA: Kenneth Cavanaugh, U.S. Food and Drug Administration

  • Academic: Aaron Lottes, Purdue University

The following sections include a description and key deliverables from each of the workstreams within the working group:

Workstream 1: Review of Global RWE Examples 

The working group reviewed the report in detail and identified examples of international RWD used to support FDA regulatory decisions. 

Workstream 2: Review of RWE Regulatory Documents

The working group also looked at available guidance documents for use of RWE.  

Based on the Review of Global RWE Examples and Regulatory Documents the group created the following mind map to describe the RWE Landscape:

Mind map of the global RWE landscape. The diagram depicts the most commonly cited quality attributes in real-world
data that may be used as evidence in the various types of studies throughout the global RWE landscape. Note that not all of these were represented in each region that was assessed. Also depicted are the business processes supported by RWE, which include regulatory activities (eg, premarket authorization and postmarket surveillance and research), as well as nonregulatory activities (e.g., product development/research, economic analysis, reimbursement, and public health surveillance).

Workstream 3: Survey of RWE Experiences

The working group conducted an industry survey to better understand RWE experiences and the uses of RWE for regulatory decision-making by gathering information on both positive and negative experiences with RWE to support regulatory decisions.

Workstream 4: Report of Finding

The working group authored a report of their activities and findings, which can be found in the Endovascular Today, August 2023 publication:

Meeting Links

The following are links to the previous RAPID Think Tank meetings and the Global Regulatory Acceptance working group updates: 

References to Guidance Documents

United States Link

  • Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics guidance for industry (Reviewed version: May 2019; Current version: September 2022)

  • United States Use of real-world evidence to support regulatory decision-making for medical devices (Reviewed (current) version: August 2017)

  • United States Data standards for drug and biological product submissions containing real-world data (Reviewed version: October 1, 2021 (*Draft))

  • United States Real-world data: assessing electronic health records and medical claims data to support regulatory decision-making for drug and biological products (Reviewed version: September 1, 2021 (*Draft))

  • United States Real world data: assessing registries to support regulatory decision making for drug and biological products (Reviewed version: November 2021 (*Draft))

  • United States Considerations for the use of RWD and RWE to support regulatory decision-making for drug and biological products (Reviewed version: December 1, 2021 (*Draft))

Japan

China

  • Technical guideline for the application of real world data in clinical evaluation of medical devices (Reviewed (current) version: November 24, 2020)

Global

 

Canada

 

Korea

  • Guideline on application of the real-world evidence (RWE) for medical devices (No translation available at time of reviewCurrent version: February 2019)

EMA

Australia

UK (MHRA)

UK (NICE)

Page updated: August 2023

Guidance Documents
Real-World Evidence Mind-Map - Landscape_4_21_Edits (1).png
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