Key milestones

– for the integration of patient
perspectives into regulatory processes

  •  

    1996

    First FDA Patient Representative sits on FDA Advisory Committee and FDA Patient Representatives receive voting rights

  •  

    2000

    Patients become full members of the EMA Committee for Orphan Medicinal Products

  •  

    2001

    FDA Patient Representative Program™ expanded

  •  

    2003

    EMA patient working group created

  •  

    2005

    EMA Framework for interaction with patient and consumer organisations adopted

  •  

    2006

    EMA Patients and Consumers Working Party (PCWP) created

  •  

    2012

    FDA Patient Focused Drug Development initiative established under the Prescription Drug User Fee Act (PDUFA)

  •  

    2015

    FDA announces launch of Patient Engagement Advisory Committee (PEAC)

  •  

    2016

    21st Century Cures Act – Directing and Enabling Patient Focused Drug Development signed into law in the US FDA–EMA Patient Engagement Cluster founded

  •  

    2017

    Systematic inclusion of real-life experience in EMA regulatory output.

    All new FDA drug approvals to include a summary of any patient experience data that was submitted and reviewed as part of the application.

  •  

    2018 / 2019

    FDA releases five PFDD draft guidances

    Guidance 1 – methods and approaches to patient input throughout the drug development process

    Guidance 2 – methods for collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy

    Guidance 3 – approaches to identifying important
    impacts to patients

    Guidance 4 – defines standards for selection, design, and development of clinical outcome assessments

    Guidance 5 – informs the use of real-world evidence as part of a regulatory submission to FDA

  •  

    2021

    FDA PFDD initiatives takes effect

  •  

    2025

    EMA Regulatory Science Strategy

  • 1996

    First FDA Patient Representative sits on FDA Advisory Committee and FDA Patient Representatives receive voting rights

  • 2000

    Patients become full members of the EMA Committee for Orphan Medicinal Products

  • 2001

    FDA Patient Representative Program™ expanded

  • 2003

    EMA patient working group created

  • 2005

    EMA Framework for interaction with patient and consumer organisations adopted

  • 2006

    EMA Patients and Consumers Working Party (PCWP) created

  • 2012

    FDA Patient Focused Drug Development initiative established under the Prescription Drug User Fee Act (PDUFA)

  • 2015

    FDA announces launch of Patient Engagement Advisory Committee (PEAC)

  • 2016

    21st Century Cures Act – Directing and Enabling Patient Focused Drug Development signed into law in the US FDA–EMA Patient Engagement Cluster founded

  • 2017

    Systematic inclusion of real-life experience in EMA regulatory output.

    All new FDA drug approvals to include a summary of any patient experience data that was submitted and reviewed as part of the application.

  • 2018 / 2019

    FDA releases five PFDD draft guidances

    Guidance 1 – methods and approaches to patient input throughout the drug development process

    Guidance 2 – methods for collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy

    Guidance 3 – approaches to identifying important
    impacts to patients

    Guidance 4 – defines standards for selection, design, and development of clinical outcome assessments

    Guidance 5 – informs the use of real-world evidence as part of a regulatory submission to FDA

  • 2021

    FDA PFDD initiatives takes effect

  • 2025

    EMA Regulatory Science Strategy