Advantages of Registering Biological and Health Products in Brazil
When it comes to health products in Brazil, understanding Anvisa’s regulatory requirements is essential. Two concepts often mentioned in this context are product registration and notification. Although both are necessary processes to guarantee the safety and efficacy of products available on the market, they have important differences in terms of criteria, requirements and procedures.
ANVISA Updates Rules for Clinical Research: Innovation and Agility in Drug Development.
In November, the National Health Surveillance Agency (ANVISA) announced important changes to its rules for conducting clinical research in Brazil. The new guidelines aim to reduce bureaucratic obstacles, speed up drug development and maintain the strict technical parameters needed to guarantee the safety and efficacy of products. Among the new features is the continuous data submission mechanism, an approach that promises to optimize the analysis and approval processes.
Mexico’s COFEPRIS establishes new electronic Appointment System
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.
Mexico’s COFEPRIS promotes the production of generic drugs with new operating rules
COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.