The Brazilian Health Regulatory Agency (ANVISA) concluded the second phase of its regulatory simplification process, in accordance with Decree n. 10.319/2019.

The Brazilian Health Regulatory Agency (ANVISA) concluded the second phase of its regulatory simplification process, in accordance with Decree n. 10.319/2019, consolidating normative acts regarded as “frequently altered”. Those normative acts were consolidated into four RDC Resolutions and one normative instruction, described as follows:

RDC n. 469/2021: approves the List of Brazilian Common Denominations (DCBs, in the Portuguese acronym) from the Brazilian Pharmacopoeia;
RDC n. 470/2021: establishes procedures for receiving documents in digital format;
RDC n. 471/2021: establishes criteria for prescribing, controlling, packaging and labeling medicines based on anti-microbe substances. Normative Instruction n. 83/2021 establishes the list of approved anti-microbe substances;
RDC n. 472/2021: consolidates technical procedures for improving ANVISA regulatory process.

According to ANVISA, the consolidation process did not result in any regulatory alterations, but improved the disposition of the regulatory stock and legal security related to those topics.