SWITZERLAND TO CUT DRUG RE-APPROVALS RED TAPE
Swiss drug regulator Swissmedic has sped up its re-approval process for medicines introduced prior to the agency's creation in 2002. The existing procedure had been criticised for being too slow and unnecessarily bureaucratic.
Imported drugs are now being considered on an individual basis, so that if a patient requires them urgently, some normal checks can be bypassed. In addition, older medicines with a well-established safety profile can now simply be re-registered without undergoing a full assessment.
Following its formation, Swissmedic decided to re-assess all medicines on the local market to harmonise regulatory procedures with the European Union (EU), although the country is not a member state. The overhaul of the regulatory system focused on eliminating administrative overlaps between the cantons -- Switzerland's semi-independent regional governments -- which had their power to grant drug approvals curtailed.
In its first year of operation, Swissmedic examined and approved 180 pharmaceutical preparations, the majority of which were reportedly specialised medicines lacking full safety and efficacy data. Up to 40 drugs with incomplete profiles were withdrawn because manufacturers decided not to conduct the additional tests. However, Switzerland's pharmacopoeia was not significantly abridged, as substitute medicines were identified in most cases.
At the end of 2005, there were still 66 medicines available in Switzerland without full documentation and Swissmedic gave the companies until January 2006 to provide the additional information. The agency expects the approval system to be functioning as originally envisaged by 2008.