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). However, additional documentation requirements may apply in such cases, depending on the product group or the impossibility of complete chemical/physical characterisation.
For example, additional data may be required on pharmacodynamics, pharmacokinetics or toxicity in order to prove that the reference medicinal product's safety and/or efficacy data are transferable.
The authorisation application must state the reasons for the type of application chosen (known API with or without innovation) and for the amount of data submitted.
If there is any uncertainty as to the product-specific documentation requirements, Swissmedic strongly recommends that the issues in question be clarified at a meeting for applicants held prior to the submission (cf. guidance document Meeting for applicants held with the Authorisation sector).
Section 1.1.1. of the guidance document (WL) Authorisation of human medicinal products with known active pharmaceutical ingredient has been adapted accordingly and section 5.10 Requirements for medicinal products with a complex, heterogenous structure has been added.
The revised WL enters into force on 15 January 2024.