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.

The division of the Manufacturer Information form into parts at the end of 2013 has also had a negative impact on the transparency of manufacturer information. As a result, it is difficult to identify deviations, says the regulator.

The greatest shortcomings are apparent in the information relating to active pharmaceutical ingredient manufacturers. Complete information that is consistent between Swissmedic and the companies concerned is essential for ensuring the safety of medicines. To improve the quality of manufacturer information and ensure that Swissmedic and the companies possess current details, a comprehensive update of all manufacturer information is regarded as essential. The possible procedure was discussed with association representatives.

New Manufacturer Information form

As a first step, the Manufacturer Information form was completely revised, with input from industry representatives, and released for use on July 25, 2016. To help manufacturers enter the correct information, explanations have also been published.

At the same time, the new form for declaration(s) by the Responsible Person (RP) also went live. This guarantees that this information – which has to be provided for all variations and new applications – is submitted in standardized form.