Swissmedic is adapting its review practice for new applications for medicinal products containing the known active substance paclitaxel as paclitaxel albumin to the new EMA guideline
Shortening of time limits for applications for new authorisation of medicinal products with known active substances without innovation under Art. 13 TPA
Swissmedic establishes the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents
