Drugs


What are Drugs?

Anvisa categorizes drugs into the following: new synthetic drugs, generic drugs, similar drugs (a generic drug marketing with a brand name), potentized medicines (homeopathic, anthroposophic and antihomotoxic), specific medicines, notified medicines (low risk), OTC (over the counter) drugs, herbal medicines, medicinal gases, biologic products and radiopharmaceuticals.


Market authorizations

The maximum timeframes for Anvisa to make a final decision regarding pre-market approvals for drugs are set by Law 13.411/2016: 120 days from the submission date of the prioritization request, for drugs in the prioritized category; and 365 days from the submission date of the request, for drugs in the ordinary category. The aforementioned timeframes may be extended by a maximum of a third.

Pre-market approvals are valid for five years from the date of their publication in the Brazilian Official Gazette, and may be renewed for equal and successive periods.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing market authorizations directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.

Applicable regulations

The main regulations applicable to market authorizations for drugs are:

  • New synthetic drugs: 
Resolution RDC 200/2017
  • Generic drugs:
Resolution RDC 200/2017
  • Similar drugs: 
Resolution RDC 200/2017
Resolution RDC 238/2018
  • Specific medicines: 
Resolution RDC 24/2011 and Resolution RDC 242/2018
  • Notified medicines:
Resolution RDC 199/2006 and Resolution RDC 242/2018
  • OTC drugs:    
Resolution RDC 98/2016, Norm IN 11/2016 and Resolution RDC 242/2018
  • Herbal medicines: 
Resolution RDC 26/2014
  • Medicinal gases: 
Resolution RDC 70/2008
  • Biologic products:  
Resolution RDC 55/2010
  • Radiopharmaceuticals:
Resolution RDC 64/2009

Clinical Trials

The regulations that normalizes the submission of clinical trials with drugs and biological products to Anvisa’s approval are the Resolution RDC 09/2015 and Resolution RDC 205/2017 (special procedure for rare diseases).