Manufacturer information data quality failings identified by Swissmedic

Medicinal product authorization holders are obliged to notify Switzerland’s regulatory authority, Swissmedic, of the companies involved in manufacturing and to have them approved.

Swissmedic has reviewed the quality of the data at its disposal and established that these contain omissions and, in some cases, are incorrect. Swissmedic attributes this situation primarily to the increased regulatory requirements over the years, particularly in relation to the level of detail of the required information.