ANVISA Publishes Database for Clinical Investigations into Medical Devices

The National Health Surveillance Agency (ANVISA) has announced the launch of a database aimed at clinical investigations related to medical devices. This initiative represents an important milestone in the health sector, promoting greater transparency, efficiency and safety in research carried out in Brazil.
Transfer certificate of GMP and Ownership of Products: What Companies Need to Know

The transfer of Good Manufacturing Practice Certificates (GMP) at Anvisa is a specific process, usually related to changes in certificate ownership due to corporate reorganization, such as mergers or acquisitions.
ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force

The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.
Clinical Trials for Drugs/Medicines in Brazil and the Clinical Trial Application process

In Brazil, clinical trials for drugs follow strict regulations, guaranteeing the safety of participants and the efficacy of the drugs being tested. The regulatory body responsible is the National Health Surveillance Agency (ANVISA), which establishes rules for conducting these studies.
Anvisa approves release of vaccine and medicine against monkey pox

Anvisa approves release of vaccine and medicine against monkey pox
Brazil’s Anvisa approves eighth cannabis-based medicinal product

Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are eight cannabis products approved by ANVISA.
Brazil’s Chamber for Drug Market Regulation discloses the annual price adjustment for drugs

On January 10th, 2022, Brazil’s Technical-Executive Committee of the Drugs Market Regulation Chamber (CMED) set at 0% (zero percent) the value of the productivity factor (Factor X) referring to the adjustment of drug prices for the year 2022.
Brazil’s Anvisa approves eighth cannabis-based medicinal product

Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are eight cannabis products approved by ANVISA.
Brazil’s Anvisa approves two new cannabis-based products

The Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are seven cannabis products approved by ANVISA.
Brazil’s Anvisa approves new regulatory framework for low-risk drugs subject to notification

The Resolution RDC No. 576/2021 and the Normative Instruction No. 106/2021 expanded the list of drugs that may have simplified registration. The notification process aims to simplify the regularization of low-risk drugs.
Brazil’s Anvisa expands the Authorization for Clinical Trials with Medicines in Brazil

Amendment of Resolution No. 9/2015, which provides for clinical trials with medicines in Brazil, allows, on an emergency and temporary basis, the use of analyses performed by foreign authorities that are members of the ICH.
Mexico’s Cofepris Submits preliminary draft amendment of the Health Products Regulation

On April 7th, Cofepris submitted a preliminary draft amendment on Heath products regulation with the goal to optimize current practices based on best practices of international regulatory agencies.