Relevant Regulatory Harmonization Initiatives
Pan American Health Organization (PAHO)/Pan American Network for Drug Regulatory Harmonization (PANDRH), MERCOSUR.
Clinical Trial Data Requirements
First, the study documentation must be translated into Portuguese (2-4 weeks). The clinical trial protocol must be approved by the institutional IRC, CONEP (if the trial is foreign sponsored), and ANVISA. ANVISA is responsible for issuing the Special Communicate (trial approval document), and import license. Documents required in the dossier are listed in Annex I of Rules for the Conduct of Clinical Research (RDC 39, June 5, 2008).
Clinical Trial Import Authorization
Importing products requires an import license. The form to request a license to import a product for a study is available in Annex III of the Rules for the Conduct of Clinical Research (RDC 39, June 5, 2008) .
Clinical Trial Estimated Timeline
According to "Clinical Trials in Brazil: Facing the Challenges"
Documentation translation: 2–4 weeks
CEP/IRC approval: 2–8 weeks
CONEP approval: 8–12 weeks
ANVISA approval (Special Communicate Issue): 4–8 weeks
ANVISA—License importation: 2–4 weeks
Total: 18–35 weeks
Clinical Trial Costs
Documentation translation: $3000-$6000 (informed consent form, investigator brochure, protocol translation)
CEP/IRC approval: No fee-$1200 (Sometimes CEP/IRCs charge an administrative fee of $250-$1200)
CONEP approval: No fee
ANVISA approval (Special Communicate) $6000 (expires after 6 months from the first site inclusion. $6000 fee is assessed after each new inclusion)
ANVISA—License importation 2–4 weeks: No fee
In-Country Manufacturing Requirements
Brazil follows Good Manufacturing Practices (GMP).
Sponsors are required to cover the costs of treatment for trial subjects in the event of an injury.
ANVISA follows the Pan American Health Organization's Good Clinical Practices. Sponsors are required to have insurance. A copy of the Good Clinical Practices is available here.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
387 clinical trials approved from June 2012 - June 2014.
Product Registration Data Requirements
Resolution no. 136/2003, which is currently under review, outlines requirements for the registration of new medicines. The registration of fixed-dose combination drugs is regulated by Resolution no. 210/2004. “Guia para Registro de Novas Associações em Dose Fixa" (in Portuguese) provides additional guidance on registering fixed-dose combination drugs.
Information for generic drug registration can be found here.Documents submitted by industry need to contain information on all pre-clinical and clinical studies completed, which includes safety and efficiacy assessments done by ANVISA's technicl team and any ad hoc consultants. Additionally, there needs to be documentation related to the active ingredient, manufacturing proces, and assessment of quality control by ANVISA.
Product Registration Timelines
Estimated timelines for new drug approval from ANVISA is 1 year.
Product Registration Costs
Charts of cost are available in the appendices here (in Portuguese).
Post Registration Labeling Requirements
Resolution no. 21/2012 outlines requirements for drug labelling. The resolution is available here (in Portuguese).
November 18, 2014.
Post Registration Pharmacovigilance Requirements
Pharmacovigilance requirements (including timelines) are listed here. The expected frequency for filing PPRs is dependent on the time elapsed since authorization is granted. Health surveillance requirements (both pre- and post-registration) are outlined in Decree 8077/2013.