Switzerland – Swissmedic Details Plans to Align Combination Product Rules With EU

The Swiss Agency for Therapeutic Products (Swissmedic) has set out plans to align its approach to drug-device combination products with that of the EU. Swissmedic is set to make the changes to ensure regulatory harmonization after the EU brings in new rules covering medical devices.

EMA set out its planned approach to combination products in draft guidelines and a question and answer document earlier this year. While EMA is still finalizing those documents, Swissmedic vowed this week to align its approach to combination products with the specifications in development in the EU.