Reviewing for any change to SPCs

[MHRA Moderator]

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.

https://mhrainspectorate.blog.gov.uk...inical-trials/

[ChrisC]

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?

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.

https://mhrainspectorate.blog.gov.uk...inical-trials/

[AleT]

Hi,

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.

[ChrisC]

Hi,

As we came across a few errors with the SPCs available on the eMC website, we began using the MHRA website too. Unfortunately, we come across even more inconsistencies between what is available on eMC and the MHRA website. This happens very frequently, every month we have to try to work out what the correct date is, they don't match between the two websites. The date of revision of text can be very different from days to years between the websites.

It is not clear what the best option for checking for SPC updates is.

Many thanks,

Chris

Hi,

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.