Emerging Markets Regulatory Tracker: Brazil (Vol. 4 No. 49)
This article was originally published in PharmAsia News
Executive Summary
Brazil publishes guidance on the implementation of its track and trace system for drugs.
The Emerging Markets Regulatory Tracker is prepared for PharmAsia News by RegLink Associates, which tracks regulatory, policy and health technology assessments around the world for biopharma and medical device executives.
Read all Breaking News from RegLink.
The previous issue of the Emerging Markets Regulatory Tracker appeared here: (Also see "Emerging Markets Regulatory Tracker: Australia (Vol. 4 No. 48)" - Scrip, 17 Aug, 2014.).
Track And Trace Implementation Guidance Issued
Brazil’s national regulatory agency, Anvisa, published guidance on Aug. 18 on the implementation of Brazil’s Track and Trace system for drugs, the National Drug Control System (SNCM). The guidance manual (IN) specifies the requirements for mandatory registration with SNCM, the data that should be made available to Anvisa, and the nature of the communication among participants within the pharmaceutical chain of distribution. The manual bas the subject of discussion within the Steering Committee for the Implementation of SNCM, which was established by ANVISA for tracking and monitoring the implementation of the national system. The Steering Committee has representation from 25 governmental agencies and other entities.