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 Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |