Swissmedic begins major rewrite of drug regulations

Following multiple changes to the Swiss Therapeutic Products Act, SwissMedic are amending the relevant ordinances and the first changes will come into effect at the start of 2018.

The first changes affect off-label dosages of paediatric medicines and definitive arrangements for medicinal products approved by Swiss cantons.

The agency plans to consult on most of the other revised legislation (Therapeutic Products Ordinance Package IV), which is scheduled to apply from 2019.  An aim of these revisions is to simplify access to medicines, particularly those with traditional uses and complementary therapies, and those already approved in the EU or a canton.

The agency is planning to significantly reduce the time available to applicants to respond to problems with submissions.  The available time looks likely to be cut from 120 days to 30 days, with the intention of improving regulatory workflows.  An applicant that doesn’t respond in time will be able to refile without regulatory prejudice but, of course, they will have lost time by having to start again with a resubmission.

Proposed improvements in drug safety will see ICH E2E guide on pharmacovigilance planning apply meaning the introduction of a Pharmacovigilance Plan, application of Good Vigilance Practice and extension of the scope of reporting obligations.

There is a real desire to increase transparency in number of ways, including by requiring licence holders for medicines containing new active ingredients to publish their clinical trial data within three months of approval.  Interestingly, Swissmedic is not being prescriptive about where the information is published.