Are you aware that new MedDRA version has been implemented recently? And how about your organization? I will point out a few pharmacovigilance and regulatory processes which are usually missed out during a MedDRA version update.
New MedDRA version is delievered twice a year to keep updated more than 100 000 terms covered by the Dictionary. In theory many of us know about this however it is rarely implemented fully in every day work.
First let’s take a closer look how MedDRA codes are updated:
The MSSO (MedDRA Maintenance and Support Services Organization) collects change requests from users during the whole year. They assess the eligibility of the requests and decides if it can be implemented in the upcoming version.
There are two MedDRA updates per year. In every March X.0 version release is distributed while in September X.1 release will be available. In the beginning of this September, version 21.1 was just released!
But be careful! A new release version of MedDRA should become the reporting version on the first Monday of the second month after it is released.
This means that you do not need to report and submit information under 21.1 version yet but this the right time to prepare for it.
Let’s see where MedDRA codes are used within a pharma company
MedDRA codes are used to ensure that pharma companies and authorities are on the same page during the whole lifecycle of a medicinal product. From clinical phase I is a long jurney to the withdrawal so I can ensure you that the documentation of the product will be updated many times by new MedDRA versions.
Keep in mind that Adverse Event Reports in clinical trials and in post-marketing, MAA, SmPC, CCDS, PIL, PSUR and RMP documentation should be always submitted under the current reporting MedDRA version!
Seems easy right? Well, not necessary..
Please think through your whole process:
• Are case processors takes into account the possible changes?
• Are you sure that your Medical Department perform the update when implement the recent updates into the SmPC?
• What happens if a new version comes into effect just before you submit the variation/renewal package?
• During xEVMPD update are you ensure that you are reporting with the last version? And what about your internal database?
There are many point which can be missed out. Therefore when your next SOP update comes spend some time to identify where is MedDRA coding is used and implement a few simple rules about version handling. It will spare you a lot of time in the future.
You can read more about MedDRA coding and version update in the official training material following the link below.