Brazil’s regulator Anvisa extends import of radiopharmaceutical drugs
Brazil’s national drug regulator Anvisa unanimously approved on Tuesday (Aug. 9) a referendum on the “temporary and exceptional” extension of the import of radiopharmaceutical drugs, in order to minimize the shortage and suppress the demand for these compounds in the country.
The decision was taken during the 14th Meeting of the Collegiate Board of Directors, whose rapporteur is Anvisa`s head Antônio Barra Torres.
Radiopharmaceutical drugs
Radiopharmaceutical drugs are radioactive compounds that have in their composition a radionuclide (radioactive isotope), responsible for the emission of radiation, chemically linked to a non-radioactive molecule that has a biological affinity for a particular organ or system, for diagnostic or therapeutic purposes.
Given the strategic aspect for diagnoses and treatments, and the technological complexity involved in this type of drug, director Meiruze Freitas confirmed the need to import these products considered “higher risk”.
“It is preferable to keep importing unregistered [products] in Brazil, surrounded by careful monitoring and protection. In some situations, Anvisa needs to make exceptional assessments like this, but always seeking to mitigate the risk, to have minimal control,” Freitas said.
