The collegiate board of directors of the brazilian national health surveillance agency anvisa, in the exercise of the powers vested by article 15, subsections iii and iv, of law no. Com a criacao da anvisa, em 1999 lei n 978299, esta passou a. The collegiate board of directors of the brazilian health surveillance agency anvisa, in the exercise of the powers vested by article 15, subsections iii and iv,of law no. Fda anvisa brazil, confidentiality commitment english. The resolution of the collegiate board of directors of anvisa. Manufacturing practice certification and good distribution andor storage practice certification. Thus, the study presents an analytical critic of the medication. Dou 03032015 regarding regulation for realization of clinical trials of medication in brazil. Comprehensive list of medical device regulations for medical devices sold in. Conduction of clinical trials with drugs in brazil requires prior approval by committees for. Brazilian health surveillance agency anvisa law no. Article 58, subsection v, paragraphs 1 and 3, the internal statutes approved under of the. Brazil medical device regulations anvisa guidelines emergo.