Regarding the understanding of the rule that deals with the conditional approval of post-registration petitions for drugs (RDC 219/2018), Anvisa informs companies about its recent amendment. Subjects related to pharmaceutical technology and active substance of biological products were included According to the …

Nowadays, it is the Resolution 47 of Anvisa’s Board of Directors (RDC), from September 8, 2009, that establishes the rules for the development, standardization, updating, publication and provision of medication package inserts. However, this year, the Act no. 14,338 from 2022 was …