List of “clone” drug applications now available
The Brazilian Health Surveillance Agency (ANVISA) recently published a list of applications relating to the simplified procedure for the approval, post-approval and renewal of generic,similar, specific, dynamized (i.e. homeopathic) and phytotherapeutic(herbal) drugs, as well as biological products linked to the technical and clinical reports of a “mother” application (related to a “mother” or reference drug). This simplified procedure is referred to as a “clone” procedure.
On May 30, 2014, ANVISA published Resolution 31/2014 that revised the simplified “clone” procedures.According to the resolution, the clone drug must be of the same dose, form and presentation as the reference drug and it can only differ from it in the brand name, packaging layout and wording of the package insert and labeling.
According to Resolution 31/2014, ANVISA will approve a clone application with a mother application that contains all the technical and clinical information needed to request the approval of a reference drug, and also has been approved, provided it complies with the aforementioned requirements.
ANVISA reports that this list of applications will be updated monthly with the data obtained from ANVISA´s Registration System (Datavisa).
Clone applications awaiting analysis are divided into two lists: the first one includes applications where the “mother” application has no pending renewal, registration or amendments, and the second list comprises applications where the “mother” application is still pending analysis by ANVISA.
This simplified procedure is currently speeding up marketing authorizations for “clone” drugs in Brazil from months or years to a few days.