Swissmedic approved 42 innovative medicinal products in 2016, compared to the 28 approved in 2015, thereby showing a 50% increase in approvals. Standard approval time in Switzerland is 330 days, however, 7 of the 42 applications were granted marketing authorisation via the accelerated 140-day procedure. In 2016, 30 requests for the fast-track procedure to be applied were submitted and 25 fast-track requests were approved.
In 2016, the total number of applications reviewed and approved under Art. 13 TPA increased from 75 to 105, an increase of 40 % on the previous year. Of the 97 authorisation applications under Art. 13 TPA that were completed in 2016, 93 were approved (96 %), three were withdrawn and one was rejected. Of the 97 completed applications, four involved the new notification of a new active substance, 14 “known active pharmaceutical ingredients with innovation“, 27 “known active pharmaceutical ingredients without innovation“, eight “known active pharmaceutical ingredients of complementary and herbal medicines“, eight “major variations“ including five additional indications, and 27 variations requiring approval.
Overall last year, a total of 12,933 applications were completed by the agency with 99% of the applications being processed within the target timelines.
Of the 30 scientific advice meetings, 18 pre-submission meetings and 17 clarification meetings requested in 2016, 44 (around 2/3rds ) were answered in writing, while face-to-face meetings took place in 21 cases.
Another area the agency focussed on in 2016 was their oversight function. Swissmedic, with the assistance of the 4 regional inspectorates, conducted 619 inspections of manufacturers and wholesalers to ensure that they were in compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), respectively.
Swissmedic received 10,047 first reports of suspected adverse drug reactions (ADRs) in 2016. As in previous years, there was again a sharp rise in the number of reports received (+21.8 %), due to an increase in the volume reported by companies. In addition, the number of follow-up reports increased by 41.7% compared with the previous year to 3,056. This puts Switzerland in 6th place worldwide in terms of reporting rate.
To read the Swiss Medic annual report, please click here.