Joint Guidance of Swissmedic and Swissethics on the Management of Clinical Trials with Medicinal Drug Products in Switzerland during the COVID-19 Pandemic

On 4 November 2020 Swissmedic and swissethics issued version 2.3 of their joint guidance.

Changes from version 2.2 (15.06.2020): changes made to the sections “Monitoring” (remote source data verification will be allowed under specific circumstances) and “Communication with Swissmedic”.

Swissmedic and swissethics recognize the impact the COVID-19 pandemic may have on the management and conduct of clinical trials. In the following, guidance is provided with respect to the management of clinical trials with medicinal drug products during the COVID-19 pandemic in Switzerland. The procedures described are aligned with the requirements laid down in the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (version 3 (28/04/2020) agreed to by the Clinical Trials Expert Group (CTEG) of the European Commission supported by the EMA, the Clinical Trials Facilitation and Coordination Group (CTFG) of the Heads of Medicines Agencies (HMA) and the GCP Inspectors’ Working Group coordinated by the EMA).

Due to the rapidly evolving situation, further updates to this guidance are possible and likely.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /