Swissmedic starts new year with updates to regulatory processes

Switzerland’s medicines regulator, Swissmedic, has updated its  guidance regarding the authorization of generic medicines with certain active pharmaceutical ingredients (API).

The regulator said in a statement that medicinal products where the known chemical API has a complex, heterogeneous structure may be deemed to be “medicinal products with a known API.”

This may require additional documentation, for example in relation to pharmacodynamics, pharmacokinetics or toxicity, in order to prove that the reference drug’s safety and/or efficacy data are transferable.