21st Dec 2016, 09:58 AM
Reviewing for any change to SPCs
As an academic sponsor we have are routinely reviewing the MHRA website for any changes to SPCs for our sponsored CTIMPs. We have put together a tracker which holds all of the IMPs, each month we search the MHRA website to see if the SPC for each IMP has been updated. As the MHRA website does not include a summary of changes or any sort of version number for the SPC, we are using the "Date of Revision of Text" found in Section 10 as our version number. We log the date of revision of text in our tracker as the version of the SPC this way we can quickly see if there have been any changes.
Without this the only way we have of reviewing for any changes is to compare the most recent SPC from the MHRA website with the SPC we hold. The eMC website does include a summary of changes, but we have seen many inconsistencies between what is available to the eMC and MHRA websites.
Our process is to check the date of revision of text, if it is different we will review for any changes and check the eMC summary. I have recently been informed that using the date of revision of text as some sort of versioning is not a reliable method. Does anyone have a different process or have any suggestions about the most effective way to maintain oversight of the SPC changes?
Thank you for your time!
21st Dec 2016, 01:42 PM
It is important that if the SPC contains the reference safety information (RSI) for the trial, then ONLY the RSI in the SPC approved by the MHRA in the clinical trial authorisation should be used for expectedness assessment and not the latest one available. Any changes to the RSI would require approval as a substantial amendment prior to use for expedited reporting purposes. For more information see the MHRA inspectorate blog.
4th Jan 2017, 10:12 AM
Thank you for your reply. We are aware that a change to the RSI constitutes a substantial amendment. However in order to know whether or not there have been any changes to the RSI we need to review the SPCs available on the MHRA website - as described in my previous post. We need to know what the best way to check for any RSI changes is?
Originally Posted by MHRA Moderator
20th Feb 2017, 12:10 PM
We use the service from the eMC to receive fortnightly updates of SPCs and we take the date in section 10 as the version date of the SPC (which would be different from the eMC date). I'm not sure why the Date of revision of text cannot be cused? That is the date the SPC has been approved by the Regulatory Agencies, therefore it should be reliable.
By the way, there are some delays in the data published by the eMC (a couple of weeks to a couple of months compared to the date in section 10), however we find it overall a reliable system and less time-consuming than checking each months for updates. However there is a cost associated with this service.