Global Regulatory Acceptance
Working Group

Working Group Overview

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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.

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

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• Industry: Melanie Raska, Boston Scientific

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

• Academic: Aaron Lottes, Purdue University

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

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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. 

•  Examples of Real-World RWE Evidence (RWE) Used in Medical Device Regulatory Decisions

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Workstream 2: Review of RWE Regulatory Documents

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

• Inventory of Global Guidance Documents

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

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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).

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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.

• Survey Results

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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:

• Current Landscape for Global Regulatory Acceptance of Real-World Evidence for Medical Devices

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Meeting Links

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

• Think Tank #3 - May 2022

• Think Tank #2 - October 2021

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References to Guidance Documents

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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))

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Japan

• Points to consider for ensuring the reliability in utilization of registry data for applications (Reviewed (current) version: March 23, 2021)

• Basic principles on utilization of registry for applications (Published March 23, 2021)

• Guidelines for the conduct of pharmacoepidemiological studies in drug safety assessment with medical information databases (Reviewed (current) version: March 31, 2014)

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China

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

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Global

• IMDRF

  • IMDRF/registry WG/N42FINAL: 2017 methodological principles in the use of international medical device registry data (Reviewed version: August 2016; Current version: March 2017)

  • IMDRF/registry WG/N46FINAL: 2018 tools for assessing the usability of registries in support of regulatory decision-making (Reviewed (current) version: March 2018)

  • IMDRF/registry WG/N33FINAL: 2016 principles of international system of registries linked to other data sources and tools (Reviewed (current) version: September 2016)

  • IMDRF MDCE WG/N57FINAL: 2019 (formerly GHTF/SG5/N3:2010) clinical evaluation (Reviewed (current) version: October 2019)

  • IMDRF MDCE WG/N55FINAL: 2019 (formerly GHTF/SG5/N1R8:2007) clinical evidence (Reviewed (current) version: October 2019)

  • Post-market clinical follow-up studies (Reviewed (current) version: March 25, 2021)

 

Canada

 

• Optimizing the use of real-world evidence to inform regulatory decision making (Reviewed (current) version: April 2019)

• Guidance on clinical evidence requirements for medical devices Reviewed version: November 202 (Current version: November 2022)

• Elements of real world data/evidence quality throughout the prescription drug product life cycle (Reviewed (current) version: March 5, 2019)

• Medical device real-world data and evidence in Canada: an environmental scan highlights (Reviewed (current) version: March 2020)

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Korea

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

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EMA

• Guideline on registry-based studies – draft proposal (Reviewed (current) version: September 2020)

• Post Authorization (Human Regulatory)

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Australia

• Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance studies (Reviewed (Current) Version: August 24, 2021)

• Risk management plans for medicines and biologicals (Reviewed (Current) Version: March 29, 2019)

• Therapeutic Goods Administration International Engagement Strategy 2021-2025 (Reviewed (Current) Version: July 26,2021)

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UK (MHRA)

• MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions (Reviewed (Current) Version: October 30, 2020)

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UK (NICE)

• Evidence standards framework for digital health technologies (Reviewed Version: December 10, 2018; Current Version: August 9, 2022)

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Page updated: August 2023