Brazil's Anvisa Pushes Expedited Approvals for Generics, Biologics

Regulatory NewsRegulatory News | 04 June 2014 |  By 

Brazilian regulator Anvisa has launched a simplified procedure (RDC No. 31) for the registration, post-registration and renewal of registration of generic, similar, herbal, biologic, “dynamized” and “specific” drugs. 

So-called "dynamized" drugs in Brazil are preparations from substances that are subjected to successive dilutions, that are administered as homeopathic, anthroposophic or homotoxicological therapy.  Specific drugs are products that do not fit into other categories and cannot be tested for bioequivalence against a reference drug.

According to Anvisa, the new procedure will reduce by approximately 30% the time that it takes for it to review and approve a marketing approval application. Companies wishing to apply for registration of medicines in accordance with the new regulation may do so exclusively via electronic application, as of 4 June 2014. 


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