Media release
Bern, 04.06.2018
“The Agency fulfils its mandate reliably and professionally,” is the positive verdict of Christine Beerli, departing Chairwoman of the Agency Council, reproduced in the 2017 Annual Report. According to Stéphane Rossini, incoming Chairman of the Agency Council, the culture of collaboration will remain a factor in ensuring that Switzerland is successful in retaining a high-quality medicines control system: “A globalised economy and the international consumption of therapeutic products entail synergies and collaboration.”
Efficiency
In 2017, Swissmedic received 287 applications for first authorisations of and major variations to innovative medicinal products; it completed 290 applications. Thirty-two innovative medicinal products were approved during the year, of which seven qualified for the fast-track procedure – with the latter, new medicines obtain marketing authorisation within 140 days provided certain conditions are met.
Ninety-nine percent of all approval applications were completed on schedule in 2017. All applications for innovative medicinal products and 89 percent of applications for non-innovative medicinal products were completed within the prescribed time limits.
Revised legal parameters and their implementation
2017 was dominated by preparations for the entry into force of the revised Therapeutic Products Act. Implementing legislation, internal processes, requirements and IT systems are undergoing complex adaptations. By 1 January 2019, Swissmedic intends to be operationally and functionally ready to conduct its business activities in compliance with the new legal requirements. The new therapeutic products legislation is intended to simplify market access to therapeutic products, improve drug safety and increase transparency.
At the same time, medical devices legislation is being adapted to the new EU provisions, which have been tightened up with the aim of increasing medical device safety and quality. This involves modifying various federal acts, revising the Medical Devices Ordinance (MedDO) in its entirety and creating a new ordinance for in-vitro diagnostics.
Combating crime related to medicinal products
Combating illegal medicinal products was a key activity once more during 2017. This is an area where national and international cooperation between authorities is crucial. In autumn 2017, Swissmedic organised the meeting of the Working Group of Enforcement Officers (WGEO) in Montreux, which was attended by more than 80 experts representing authorities in 26 countries.