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  • Information Outcomes From Regulatory Processes: Regine Lehnert

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    The document discusses how regulatory authorities in Europe and through the WHO Prequalification Programme share information from their regulatory processes. It describes goals of improving health protection and transparency. In Europe, the EMEA collaborates with over 4,000 experts across 40 countries. It evaluates applications for marketing approval and monitors safety. Assessment outcomes like EPARs and public assessment reports are published. The WHO publishes public assessment reports following a similar structure to provide transparency around prequalified medicines.

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    4-3_InformationOutcomes

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    The document discusses how regulatory authorities in Europe and through the WHO Prequalification Programme share information from their regulatory processes. It describes goals of improving health protection and transparency. In Europe, the EMEA collaborates with over 4,000 experts across 40 countries. It evaluates applications for marketing approval and monitors safety. Assessment outcomes like EPARs and public assessment reports are published. The WHO publishes public assessment reports following a similar structure to provide transparency around prequalified medicines.

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    31 views27 pages

    Information Outcomes From Regulatory Processes: Regine Lehnert

    Uploaded by

    jodi
    The document discusses how regulatory authorities in Europe and through the WHO Prequalification Programme share information from their regulatory processes. It describes goals of improving health protection and transparency. In Europe, the EMEA collaborates with over 4,000 experts across 40 countries. It evaluates applications for marketing approval and monitors safety. Assessment outcomes like EPARs and public assessment reports are published. The WHO publishes public assessment reports following a similar structure to provide transparency around prequalified medicines.

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    of 27

    Information outcomes from

    regulatory processes
    Regine Lehnert

    Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data
    which are submitted to regulatory authorities, February 2009

    Synopsis
    Sharing information
    Goals
    Tools/Ways
    - in Europe
    among authorities
    with the public
    - in WHO Prequalification Programme
    2|

    Artemisinin combined medicines, Kampala, February 2009

    Sharing information
    Goals
    Improving health protection
    making regulatory processes more efficacious
    avoiding duplication of work
    Improving transparency

    3|

    Artemisinin combined medicines, Kampala, February 2009

    Sharing information in Europe (I)


    EMEA - scope
    scientific resources
    - of 40 competent authorities
    - in 30 countries
    - with over 4,000 European experts
    Collaboration with WHO, ICH,
    European Pharmacopoeia

    4|

    Artemisinin combined medicines, Kampala, February 2009

    Sharing information in Europe (II)


    EMEA - tasks
    evaluation of applications for European
    marketing authorisation for medicinal products
    monitoring of safety through pharmacovigilance
    network
    stimulating pharmaceutical innovation and
    research by scientific advice and protocol
    assistance.

    5|

    Artemisinin combined medicines, Kampala, February 2009

    Sharing information in Europe (III)


    Networking Tools
    Scientific discussions/exchanges in each procedure
    Regular assessors meetings
    Telematics
    - EudraServices,
    e.g. EudraLink
    - EudraData Warehouse,
    e.g. EudraCT, EudraGMP, EudraVigilance

    6|

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes Europe (I)


    EMEA publications on medicinal products
    EMEA Press releases, e.g. on committee meeting
    outcomes, on withdrawals of applications and on refusals
    Public statements on general, mostly technical issues
    CHMP-Summaries of opinions on positive
    recommendations for medicinal products
    European Public Assessment Reports (EPARs) on
    approved products
    Product safety announcements on pharmacovigilance
    issues.

    7|

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes Europe (II)


    What is an EPAR?
    Scientific conclusion reached by the CHMP
    Summary on the grounds for opinion
    Information for the public after deletion of confidential data

    Who is in charge of the EPAR?


    Drafted by EMEA (SOP in place)
    Usually involvement of Rapporteur
    Agreement of Marketing Authorisation Holder
    8|

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes Europe (III)


    EPAR Structure
    Summary for the public
    All authorised presentations
    Scientific discussion
    Procedural steps taken before authorisation
    Steps taken after authorisation
    Product Information

    9|

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes Europe (IV)


    Product Information
    Annex I - Summary of product Characteristics
    Annex IIA - Marketing Authorisation Holder
    responsible for Batch Release
    Annex IIB - Conditions of the Marketing Authorisation
    Annex IIIA - Labelling
    Annex IIIB - Package Leaflet

    10 |

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes Europe (V)


    How to get the information?

    http://www.emea.europa.eu

    11 |

    Artemisinin combined medicines, Kampala, February 2009

    How to get the information


    http://www.emea.europa.eu

    12 |

    Artemisinin combined medicines, Kampala, February 2009

    How to find an EPAR

    13 |

    Artemisinin combined medicines, Kampala, February 2009

    14 |

    Artemisinin combined medicines, Kampala, February 2009

    Atripla
    15 |

    Artemisinin combined medicines, Kampala, February 2009

    16 |

    Artemisinin combined medicines, Kampala, February 2009

    How to find an EPAR

    17 |

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes Europe (VI)


    Public assessment reports by National
    regulatory authorities - in English
    legal obligation to make information on medicinal
    products publicly available
    Guidance and template:
    http://www.hma.eu/uploads/media/BPG_PAR.pdf
    Examples:
    - United Kingdom: MHRA
    - The Netherlands: CBG-MEB
    - Norway: Statens legemiddelverk
    18 |

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes WHO (I)


    WHOPAR-Guideline

    19 |

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes WHO (II)

    20 |

    Artemisinin combined medicines, Kampala, February 2009

    Assessment
    Outcomes
    WHO (III)

    21 |

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes WHO (IV)


    Structure

    Part 1: Abstract
    Part 2: All accepted presentations
    Part 3: English package leaflet
    Part 4: English summary of product characteristics
    Part 5: English labelling
    Part 6: Scientific discussion
    Part 7: Steps taken for prequalification

    Part 8: Steps taken after prequalification


    22 |

    Artemisinin combined medicines, Kampala, February 2009

    Assessment outcomes WHO (V)


    How to get the information?

    http://www.who.int/pq

    23 |

    Artemisinin combined medicines, Kampala, February 2009

    24 |

    Artemisinin combined medicines, Kampala, February 2009

    How to find an WHOPAR

    25 |

    Artemisinin combined medicines, Kampala, February 2009

    26 |

    Artemisinin combined medicines, Kampala, February 2009

    27 |

    Artemisinin combined medicines, Kampala, February 2009

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