Posted 08 August 2014
By Louise Zornoza, RegLink News
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Brazil’s national regulatory agency, Anvisa, announced on 4 August 2014 that it has opened consultations on two separate proposed regulations that would amend existing procedures governing clinical trials with both drugs and medical devices.
The first, CP 64, targets medical devices, and was prompted by ongoing discussions at the International Medical Device Regulators Forum (IMDRF) on the requirements set forth in ISO 14155/2011, which defines internationally recognized good clinical practice for trials on humans involving medical devices.
The second, CP 65, would substantively amend the existing regulation governing clinical trials with pharmaceuticals by having the agency focus on risk management during the conduct of a clinical trial.
Anvisa would review a clinical trial protocol and each phase of the trial would first require the agency’s approval before the trial could continue. Interested parties have 30 days to submit comments.