Industry's perspective Particular challenges for a pharmaceutical company

Different challenges for industry may occur before and throughout the registration process with a known herbal active substance in Switzerland. Using an EU-CTD-dossier it will be lined out what changes an applicant has to implement before a submission of a registration application in Switzerland (e.g. the “helvetisation” of module 1).

If the applicant is also marketing authorization holder in other European and non-European countries special challenges exist with regard to the CMC part (module 3). Country-specific quality requirements of different health authorities have to be considered and feasible and reasonable specifications have to be set up.

Furthermore as an example, in the non-clinical part (module 4) for known herbal active substances Swissmedic may request genotoxicity tests as well as interaction studies.

For the clinical part (module 5), especially the conduct of clinical trials The Human Research Act (HRA) and its corresponding ordinances are in force in Switzerland since 2014. The Ordinance of Clinical Trials in Human Research (ClinO) as well as the Human Research Ordinance (HRO), Ordinance on Human Research with the Exception of Clinical Trials and their peculiarities will be outlined. The author shares some insight in first experiences of human research projects belonging to both ordinances and compares the Swiss situation to the European/international requirements for clinical trials.

In Switzerland – in contrast to many other countries – there exists pharmaceutical reimbursement and pricing policies for herbal medicines. The authors will outline these policies more in detail and share own experiences with the audience.