Brazil speeds up approval process for generics and biologicals

Home/Guidelines | Posted 06/06/2014 post-comment0

Brazil’s National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária, ANVISA] announced on 3 June 2014 the publication of a new guideline for generics and biologicals aimed at speeding up the regulatory procedure.

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The new guideline (RDC 31/29 May 2014) provides for a simplified procedure for requests for registration, post-registration and renewal of registration of generic, similar (medicamentos similares), specific*, energized#, herbal and biological drugs.

ANVISA estimates that the new procedures will reduce the time to registration in Brazil by approximately 30%. 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.

ANVISA and the Brazilian Government have several initiatives ongoing to improve the availability of medicines to the Brazilian population. ANVISA recently proposed that 'medicamentos similares' should be interchangeable with their reference drug in the same way as generics are, thereby reducing their cost; generics must be priced 35% lower than the reference product category [1]. While the Brazilian Government has proposed that medicines be exempt from tax [2].

*Specific drugs are products that do not fit into other categories and cannot be tested for bioequivalence against a reference drug.

#Energized drugs are preparations from substances that are subjected to successive dilutions, that are administered as homeopathic, anthroposophic or homotoxicological therapy.

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1. GaBI Online - Generics and Biosimilars Initiative. Brazil to designate medicamentos similares as interchangeable []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 6]. Available from:

2. GaBI Online - Generics and Biosimilars Initiative. Proposal in Brazil to exempt medicines from tax []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 6]. Available from:

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Source: ANVISA

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