Brasília – Anvisa has launched a directed public consultation to update the list of radiopharmaceuticals classified as “recognized use,” as defined by Normative Instruction 81/2020. The agency is seeking contributions on new radiopharmaceuticals that could be added to this list.

Recognized-use radiopharmaceuticals are those with proven safety and efficacy in scientific literature, and as such, do not require specific clinical trial data. These products are already widely used in clinical practice and are technically and scientifically validated.

Due to recent shifts in Brazil’s radiopharmaceutical market, Anvisa has deemed it necessary to re-evaluate the current list to align it with sector demands, population needs, and the prevailing technical-scientific context.

The update will follow criteria set by Board Resolution (RDC) 738/2022, including:

Approval of the drug’s registration for at least 10 years in countries with a regulatory framework equivalent to Anvisa’s; or

Recognized clinical use for at least 10 years in Brazil or abroad, with demonstrated efficacy and safety through accumulated usage.

The consultation remains open for 30 days, ending on September 12. All submissions will be reviewed by Anvisa and may lead to updates in the regulation.

Source: Anvisa

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