Drugs

The regulation of health related products and services is part of the scope of work of the Brazilian Health Regulatory Agency (Anvisa), including the authorisation of clinical trials conducted in the country and active pharmaceutical ingredients (API) and marketing authorisation of drugs and biological products and post-marketing variations.

Anvisa has the following regulatory categories of drugs: new synthetic and semi-syntheric drugs, generic drugs, similar drugs (branded generics), 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.

Clinical Trials 

The regulations related to 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).

Marketing authorisations (MA) 

The review of drug MA applications are conducted according to the Brazilian legal framework, regulations and guidelines, following the Good Review Practices and other international guidelines to ensure that approved drugs comply with safety, efficacy and quality requirements.

 The review time and deadlines for Anvisa issuing a final decision regarding marketing authorization (MA) approval for drugs are 120 days for dossiers granted priority review, and 365 days for ordinary MA reviews. The aforementioned deadlines are set by Law 6360/1973 and can be extended by a maximum of a third of these periods.Marketing authorisation (MA) approval is valid for ten years from the date of their publication in the Brazilian Official Gazette (DOU) and may be renewed for equal and successive periods, except for drugs approved with preliminary evidence with “commitment term” (“termo de compromisso”), to which the MA is valid for three years, five years after the first renewal and ten years after the second renewal consecutively as established by Law 6360/1973 and RDC 317/2019.

For submitting marketing applications at Anvisa, Foreign companies shall have a partner company legally constituted in Brazil that will be legally responsible for marketing authorisation, importing, distribution and post-marketing surveillance in the Brazilian territory.

Applicable regulations

The main regulations applicable to market authorizations for drugs are:

Post-marketing Variations

Applications for post-marketing variations subjected to immediate implementation (notification) or those which require  Anvisa’s approval to be implemented are listed on Annex I of RDC nº 73/2016. More information is available at Questions and Answers of RDC 73/2016 Edition 5 - September/2023The review time and deadlines for Anvisa issuing a final decision regarding drug’s variations (post-marketing changes) are sixty days for drugs under priority review and 180 days for ordinary applications. The deadlines are set by Law 6360/1973 and can be extended by a maximum of one third of these periods.