"Swissmedic performs its mandate independently, professionally and in a spirit of innovation": that was the positive verdict expressed by Stéphane Rossini, Chairman of the Agency Council, in the 2018 Annual Report. The principal aim is, and will remain, to ensure the effective and impartial control of therapeutic products in close cooperation – and as part of an ongoing dialogue – with national and international regulatory authorities and other healthcare stakeholders.
Bern, 29 May 2019
At the same time, the Agency has to keep up with advancing digitalisation so that it can perform its increasingly complex tasks even more efficiently. Last year, in formulating its strategic objectives for the period 2019-2022, the Agency Council identified the current challenges and fixed its priorities. The Federal Council has approved the objectives and thus confirmed their importance.
In 2018, Swissmedic received 352 applications for innovative first authorisations of and major variations to innovative medicinal products; it completed 377 applications. Thirty-two innovative medicinal products were approved during the year, of which four qualified for the fast-track procedure – with the latter, new medicines obtain marketing authorisation within 140 days provided certain conditions are met.
99.4 percent of all approval applications were completed on schedule in 2018. 99.7 percent of applications for innovative medicinal products and 94.3 percent of applications for non-innovative medicinal products were completed within the prescribed time limits.
Implementation of the revised legal parameters
Like the previous year, 2018 was dominated by preparations for the entry into force of the revised Therapeutic Products Act. Swissmedic's objective was to be operationally and functionally ready to conduct its business activities in compliance with the new legal requirements as of 1 January 2019. The new therapeutic products legislation simplifies market access for therapeutic products, increases safety and improves transparency.
Changes to dispensing categories
In revising the Therapeutic Products Act, the government decided to simplify the rules on self-medication and make fuller use of the dispensing outlets' specialist competencies. Under the revised Act, there are now only four dispensing categories: dispensing category C ("pharmacy only") has been dropped. Around 650 medicinal products in this category were assessed according to scientific criteria and with the involvement of external specialists. It was proposed that 85 percent of these be assigned to dispensing category D (dispensing by pharmacies and druggists).
The 540 medicinal products in dispensing category D were also examined: it was recommended that 17 percent of these be assigned to dispensing category E (self-serve basis without expert advice). As a result, dispensing category E has been expanded to include 240 medicinal products. All the other products are intended for the treatment of illnesses that require expert advice and must therefore remain in the corresponding dispensing categories.
Reclassification is taking place in 2019, with the individual decisions being published in the Swissmedic Journal as they take legal effect. Existing packaging can continue to be supplied to dispensing outlets for one year, but within two years after reclassification at the latest all changes must have been implemented on packaging and in the product information.
At the end of last year, Swissmedic employed 425 persons (prior year: 424), and the number of full time equivalent positions was 350 (349).
At the end of 2018, 8,259 medicinal products were approved by Swissmedic for the Swiss market, 715 of them veterinary medicinal products. The number of homeopathic and anthroposophic medicinal products without an indication authorised under the notification procedure was also virtually unchanged (11,041 single products and 1,008 combined products).
1,479 applications to extend marketing authorisation were received last year (2017: 1,276). In addition, there were 274 (274) applications for the discontinuation of a preparation or a dosage strength. Authorisation holders opted not to extend the authorisations of 65 (106) products.