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Compliance % and/or delays limit acceptable for ICSR submission

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  • Anshu Tomar
    04/01/2018 09:52
    Hi all, Need GPvP (Pharmacovigilance Input)!! Tried searching in EU and FDA regulations (Good Pharmacovigilance Practices-GPvP) regarding requirements for compliance and % delays limit acceptable for ICSR submission, if any. However, could not trace any concrete details. Though quite an obsolete data still, please find below the link (Slide no.22) which gives insight into the compliance expectations. No other reference data is available. http://www.pvinspections.glasgows.org/files/pv/5%20J.%20Rowell%20-%20PSMF%20-%20Your%20Questions%20Answered.pdf Please advise if there is any permissible limit of % or count for delayed submissions which is acceptable by regulatory authorities. Thanks & Kind Regards, Anshu
  • Dagmar Gauweiler
    24/01/2018 18:04
    Hello there, there is no general rule for what is considered an acceptable compliance, however, for EU the 95% provided in the MHRA inspectors' presentation still seem reasonable. If you have a pronounced dip in compliance, it might be good to notify the authorities pro-actively to indicate that you are aware of the problem and you're addressing it. In this case, you should also include a description of your corrective/preventive action. MHRA used to do their own compliance checks and they would write to the QPPV if compliance for the last quarter was below 90%, requesting an explanation. I believe with the new EV functionality, the EMA compliance checks will be resumed (they did a pilot some years ago) and they may carry on the MHRA's practice. It might be worth checking EMA's procedures (I believe they are all published on the website) to see whether they have any provisions for this. In US, tolerance for late submission is much lower and US PV functions usually aim for a compliance of at least 98%.
  • Anshu Tomar
    26/01/2018 02:40
    Thank you for this detailed insight. This is really helpful. If that is the case can a CRO handling ICSR service of MAH, document deviation only to investigate event where compliance % goes below 98 % threshold and define CAPA accordingly or deviation to be raised for each late case submission. Please advise.
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