Introducing a new form for drug safety signals regarding human medicinal products

The Swiss Agency of Therapeutic Products (Swissmedic) has created a new Signal Notification Form as part of its plan to make safety data collection more efficient.

Starting in January 2020, the new form is to be used for reporting initial and follow-up safety signals that lack a Swissmedic Signal ID. Furthermore, a cover letter will not need to be submitted.

The notification form will capture critical information about the marketing authorisation holder (MAH), the product involved and the safety issue. MAHs will be required to describe the safety signal, discuss existing or planned risk minimisation measures in other states, and explain how they will manage the threat to Swiss patients. MAHs will also need to elucidate any differences between global and national risk minimisation plans. Additional documentation relating to the signal report including assessment reports, detailed statements and references should be appended to the notification form.

However, Swissmedic will still require MAHs to use a different process when submitting information about signals that already have a signal ID. MAHs will need to attach a covering letter with a subject line that states the Signal ID and further key information, such as the name of the active substance involved.

Overall, the new form should standardise the structure of reporting signals increase efficiency of data collection.

To view the new form and the related updated guidance, click here.