To face the COVID-19 pandemic, ANVISA amends norm so that advanced therapy products not eligible for registration can already be used in Brazil

On 30 March, 2020, ANVISA approved a resolution aimed at accelerating the prior authorization and communication process for products used in advanced therapy. This decision seeks to incentivize and operationalize the research for new treatments to the new coronavirus. The provisions of RDC nº 363 allow for an earlier entry into force of provisions already present in a prior RDC nº 338.

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