On 9^th April 2020, Swissmedic published an update on the implementation of ICH Q12 in Switzerland. As an ICH member Switzerland also follows the EMA in implementing this guideline. Swissmedic applies this guideline, with restrictions concerning “established conditions” and the “PLCM” (Product Life Cycle Management) document, to all applications submitted from 1^st April 2020 onwards. Follow the link for the full update.

Follow the link for the full update: https://www.swissmedic.ch/swissmedic/fr/home/news/mitteilungen/ich-guideline-q12.html