Medicinal Products

The regulation of health-related products and services is part of the work scope of the Brazilian Health Regulatory Agency (Anvisa), including the authorization of clinical trials conducted in Brazil, active pharmaceutical ingredients (API) and marketing authorization for medicines and biological products, as well as post-marketing changes.

Anvisa has the following regulatory categories of medicinal products: new synthetic and semi-synthetic medicines, generic medicines, similar medicines (branded generics), potentized medicines (homeopathic, anthroposophic, and antihomotoxic), specific medicines, notified medicines (low risk), OTC (over the counter) medicines, herbal medicines, medicinal gases, biological products, and radiopharmaceuticals.

Clinical Trials

The regulations related to the submission of clinical trials with medicinal products and biological products to Anvisa’s approval are Resolution RDC 945/2024 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.

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.

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 for synthetic drug products (including generic and similar), in RDC nº 76/2016 for specifc medicines and in RDC nº 708/2022 for herbal medicines. The 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.