Brazil Profile Updated with Amendment to Rare Diseases Resolution

December 13, 2022
Subscribe to these updates

The Brazil profile in ClinRegs has been updated to include RDC No. 763, of November 25, 2022, which amends RDC No. 205, of December 28, 2017. A pre-submission meeting related to an application to conduct a clinical trial of a rare disease is now only required if deemed necessary by the applicant. (See Scope of Assessment and Timeline of Review)

Sources Revised During this Update:
(Regulation) Resolution of the Collegiate Board - RDC No. 205 of December 28, 2017 (ResNo205 - Portuguese) (GoogleTranslate-ResNo205) (Effective February 27, 2018)
ANVISA, Ministry of Health

Sources Added During this Update:
(Regulation) Resolution of the Collegiate Board - RDC No. 763 of November 24, 2022 (ResNo763 - Portuguese) (GoogleTranslate-ResNo763) (Effective December 1, 2022)
ANVISA, Ministry of Health

Back to list