5. Juli 2024 – The Swiss Public Assessment Report (SwissPAR) is a summary, public evaluation report drafted by Swissmedic that relates to an authorisation procedure. The SwissPAR is produced for all human medicinal products with a new active substance and transplant products for which a new authorisation application has been approved or rejected by Swissmedic. Therein Swissmedic publishes both the proposed and approved indications in the SwissPAR. The applicant may request that Swissmedic refrain from publishing the proposed indication insofar as this would disclose commercial or manufacturing secrets. To date, Swissmedic has not always assessed the validity of such claims stringently.

Swissmedic is standardising its practice and in future will consistently assess and decide on applications for confidentiality of the proposed indication according to the criteria published in the “Commercially Confidential Information (CCI)” section of the Guidance document SwissPAR. The new practice and revised guidance are effective from 1 July 2024.

For more information, see here.