Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 08 August 2014 | By Louise Zornoza
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
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.
Tags: Brazil, Clinical Trial Regulations, IMDRF