Swissmedic Annual Report 2018

Market access | Licensing
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Clinical trials with medicinal products
Clinical trials are used to systematically gather information
on medicinal products when used in humans. Swissmedic
verifies whether the quality and safety of the test product is
guaranteed. Clinical trials may only be carried out in Switzerland
if they have been approved by an Ethics Committee
and by Swissmedic.
Activities
• Swissmedic received 180 applications for clinical trials
with medicinal products in 2018. However, it was only
possible to process 175 of these because the rest were
either incomplete or fell outside the remit of the Clinical
Trials division.
• In total, 176 clinical trials were approved, including 25 in
category B and 151 in category C. Four of the applications
in the latter category concerned a first-in-human
trial. One clinical trial was rejected, and two were
withdrawn by the sponsor during evaluation. The other
applications are currently being processed. The trend
observed in 2016 and 2017 towards more complex
products and, as a result, more complex dossiers
continued during 2018.
• On the other hand, 2,866 other requests or notifications
relating to clinical trials of medicinal products were
processed (amendments during the course of clinical
trials, end-of-trial notifications, Annual Safety Reports,
end-of-trial reports) as well as 128 reports of suspected
unexpected serious adverse reactions (SUSARs).
• Swissmedic continued to work with the FOPH and swissethics,
the Association of Swiss Ethics Committees, on
research involving humans, with the aim of coordinating
and harmonising the three bodies’ interpretation of
certain legal provisions. In connection with these
efforts, Swissmedic took part in four meetings organised
by the FOPH’s Coordination Office for Human
Research. The new Clinical Trials Symposium started in
2017 was successfully repeated during 2018, and will
now become an annual fixture. The aim of this form of
information dissemination is to provide training to one
or two individuals in each organisation (e.g. clinical trial
units) so that they can then train others at local level.
The symposium will replace the numerous presentations
that used to be given to these organisations.
2018
180 176
2017
198 193
2016
206 185 3
Clinical trials: (processable) new submissions
Approved clinical trials
Submitted trials, rejected
2