BIO Comments on Brazil’s ANVISA Public Consultation #65, Regulating Clinical Trials (submitted September 9 2014)
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The Biotechnology Industry Organization (BIO) welcomes the opportunity to provide comments to Public Consultation #65 published by the Board of Directors of the National Health Surveillance Agency on August 4, 2014 which proposes a new regulation defining the procedures and requirements for conducting clinical trials involving drugs in Brazil.</p>
The Biotechnology Industry Organization (BIO) welcomes the opportunity to provide comments to Public Consultation #65 published by the Board of Directors of the National Health Surveillance Agency on August 4, 2014 which proposes a new regulation defining the procedures and requirements for conducting clinical trials involving drugs in Brazil. Public Consultation #65 also includes rules for the production of a drug clinical development dossier (DCDD) that is to be closely monitored by ANVISA through the entire clinical development of a drug and which ultimately will serve as the basis of a drug market approval application.
BIO hopes that its contributions below to the Public Consultation represent just the first of several opportunities to engage with ANVISA on developing positive and clear regulations on clinical trials that help to create a regulatory environment that places patient safety at the forefront while also driving technological advances and spurring innovation in the biopharmaceutical field.
Please find links to BIO’s full comments below, in both English and Portuguese.
