Patient Identifiers vs valid reports – MHRA

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  • #42677
    rita.bildoy@ge.com
    Participant

    Hello!

    One question regarding patient IDs for a valid report in the UK.
    As you will be aware of, EMA has a stricter approach than the FDA regarding patient IDs for a valid report:
    – while FDA considers a define # of patients to be sufficient proof that a patient exists (even if no other patient IDS like name initials, DOB, gender etc are available); EMA considers only reports to be valid if a standard patient ID is gathered.
    There was a question regarding this on our case processing team (based in the US) – after Brexit, does the MHRA align fully with the EMA regulations on this respect, or are they open to receive reports where just “a patient”; “3 patients” etc are identified? I do believe the Human Medicine Regulations fully align with the EMA on this respect, but wanted to gather others’ perspectives.
    Thank you!

    #42731

    hi, I have the same question,
    as per GVP module ,

    ” identifiable ” refers to the possibility of verification of the existence of a patient based on the available information.

    #42808

    Hi,

    As per the guidance v2 “Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority” released by the MHRA, there is no modification to the term identifiable patient. So the GVP module definition of identifiable patient applies for UK as well.

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