Swissmedic and the pharmaceutical industry meet regularly to discuss topics relating to GMP/GDP and establishment licences at a Round Table on GMP/GDP (referred to below as the "Round Table”). The Round Table enables all parties to make their concerns heard in order to respond promptly and appropriately to regulatory and technical signals, as necessary. For Swissmedic the Round Table is a platform for exchanging information and experience on a technical level. Changes in the field of GMP/GDP are discussed with representatives of the pharmaceutical industry before the change is made, so that practical aspects of operational implementation can be properly taken into account and communicated appropriately to the target audience.
The Round Table comprises representatives of the pharmaceutical industry and its associations plus senior representatives of the regional inspectorates and senior representatives of the Inspectorates and Licences Department at Swissmedic. The direct exchange between Swissmedic and the pharmaceutical industry has proved to be a productive way of promoting mutual understanding of the parties’ concerns as well as for planning and implementing regulatory, process-related and technical changes in an efficient manner.
The Round Table’s guidelines for cooperation are set out in the Terms of Reference.