Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients (API), temporary authorization, products that receive fast-track authorization, and other documents how it authorizes products under the Therapeutic Products Act (TPA).
The agency said it updated its guidance on APIs to reflect its thinking on how complex or heterogenous APIs are reviewed before being allowed on the market.
“Medicinal products whose known chemical active pharmaceutical ingredient has a complex, heterogeneous structure (or with a formulation of this active pharmaceutical ingredient that is complex and heterogeneous) may be deemed to be medicinal products with a known active pharmaceutical ingredient (known API, with or without innovation),” said Swissmedic. “However, additional documentation requirements may apply in such cases, depending on the product group or the impossibility of complete chemical/physical characterization.”…
