ORBIS Compliance

Brazil's ANVISA removes barriers to importing vital drug against rare cancer

Published /Effective /Brazil

In a recent decision adopted by the National Health Surveillance Agency (ANVISA), measures were approved to facilitate access to chemotherapy drugs that are not currently registered in Brazil, specifically those containing the active ingredient mitotane.

This compound is crucial for the treatment of unresectable or metastatic adrenocortical cancer, a rare and highly aggressive tumor affecting the adrenal gland.

Until now, Brazilian health services required prior exceptional authorization from the ANVISA Board of Directors (Dicol) to import mitotane, due to the lack of registration of the product in the country.

WHOM DOES IT IMPACT?

The direct impact is on public health, the health system, importers and manufacturers, and consumers.

CONCLUSION:

This measure has a high impact because it responds to an urgent need for the treatment of a rare and serious cancer, directly benefiting patients and improving the efficiency of the public health system. It also strengthens the proactive role of the State in the face of shortages of essential medicines.

Regulatory Authority

ANVISA

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

Talk to our Experts

Let us clarify how this news impacts you. Fill the form below and we will get back to you within 24 hours.

Gain comprehensive insights and the latest regulatory updates from around the globe with ORBIS Compliance's product certification management resources. Discover how to utilize these tools by completing our brief contact form for more information.