Swissmedic is supplementing its existing guidance documents with a structured collection of FAQs on key requirements and procedures relating to the risk management of human medicinal products
Swissmedic specifies the requirements for the presentation of undesirable effects and interactions and adds information on environmental and disposal aspects
The Guidance document Drug Safety Signals HMP has been comprehensively revised, its structure has been modified and its content has been clarified; in parallel, the Signal Notification Form has been revised and adapted to the new requirements
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
