The Brazilian Health Regulatory Agency (ANVISA) launched two public consultations on the registration process of new innovative synthetic and semisynthetic drugs, for a period of 60 days. They seek to facilitate the administrative process regarding registration and safety and efficacy assessment.
The launch of two public consultations on new innovative drugs relates to a regulatory problem regarding the registration process within the Brazilian Health Regulatory Agency (ANVISA), ruled by RDC Resolution n. 60/2014, which lacked a proper category of registration for synthetic and semisynthetic drugs of new and innovative character. Contributions can be submitted until December 28.
Public consultation n. 931/2020 presents a draft normative instruction on code definitions within ANVISA’s administrative protocol for the registration of synthetic and semisynthetic drugs of new and innovative character. Contributions can be submitted through this digital form, where more information can be found (in Portuguese).
Public consultation n. 932/2020 concerns to an amending proposal to RDC Resolution n. 200/2017, regarding safety and efficacy assessment of drugs with synthetic and semisynthetic active ingredients and the criteria for concession and renewal of registration. Contributions can be submitted through this digital form, where more information can be found (in Portuguese).
