Use Of IB Updates As RSI For Multi-Country Trials

Hi all

Following guidance from the MHRA and our SOPS. We only use an updated IB as an RSI when the version has been approved by all countries. However, we are in a situation where by we submitted an amendment to the MHRA to use a new version of the IB (v24) and this was approved we then submitted this amendment to the DKMA to use this version of the IB. However, they have rejected this amendment as they are aware that in the time this has taken there has been an even newer version of the IB released (v25) and they will only approve the use of the latest version. However, this version is not the version that has been submitted and approved by the MHRA.

I have two questions;

1) how do you manage your process for IB updates for international trials – do you run the process concurrently e.g. submit to the MHRA and DKMA at the same time or do you submit to MHRA and gain approval and then submit to the other regulatory bodies?

2) can you see any reason why we can’t allow the DKMA to approve v25 for use as part of this amendment (as they have agreed to do) rather than them reject the amendment and us have to resubmit and then submit to the MHRA for approval whilst waiting for the DKMA to approve?

To add to the situation we had asked for the MHRA to approve v24 from the CTA date which is June. So if we follow what the DKMA require we will be switching to v25 mid DSUR period.

Interested to know your thoughts…

Kelly

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