How Avisalegis Can Make It Easier to Follow ANVISA Regulations
What is Avisalegis and How Does It Impact the Healthcare Industry? The National Health Surveillance Agency (ANVISA) recently launched Avisalegis, an innovative service that allows you to receive alerts about new regulatory publications. With this tool, medical device manufacturers, pharmaceutical companies, and other regulated industries can quickly keep up with any updates that impact their […]
QR Group Explains Anvisa’s Approval of 124 Drugs for Rare Diseases
Advanced Regulation Boosts Treatments for Rare Diseases Anvisa has played a key role in the approval of drugs aimed at rare diseases, achieving a total of 124 approvals in the last eight years. This advance reflects the agency’s commitment to optimizing regulatory processes, ensuring more therapeutic options for patients facing diseases that are often chronic, […]
Review of RDC 81/2008 and its Impacts on Imported Products
Understand How the Regulation Update Affects the Import of Health Products and How QR Group Assists Companies in the Process On May 15, the National Health Surveillance Agency (ANVISA) approved the Regulatory Impact Analysis Report (RAIR) regarding the revision of the Technical Regulation of goods and products imported for health surveillance purposes. This step represents […]
Anvisa Gets a Grade 10 Performance in Good Regulatory Practices: Understand the Impact and How QR Group Can Help in the Process
CGU audit recognizes Anvisa’s excellence in good regulatory practices; learn how this reflects on healthcare product regulation and how QR Group supports manufacturers. The Office of the Comptroller General of the Union (CGU) recently evaluated Anvisa, along with other regulatory agencies, regarding the adoption of good regulatory practices. Anvisa stood out for meeting all the […]
QR Group Explains Changes in ANVISA Cosmetics Regulation
Understand how the migration to the Solicita platform impacts the regularization of cosmetics in Brazil and how QR Group can assist in this process. ANVISA announced the extension of the deadline for the migration of the Cosmetics Registration Automation System (SGAS) to the Solicita/Datavisa platform. With the effectiveness of RDCs 949/2024 and 951/2024, the new […]
Evolution of Regulation for Rare Disease Drugs in Brazil
Understand how ANVISA’s regulation has accelerated the approval of drugs for rare diseases and the impact on international manufacturers. Health regulation in Brazil has undergone significant advances in recent years. One of the most impacted sectors is medicines for rare diseases, which registered a significant growth in the number of approvals by ANVISA. In the […]
Update on Smoking Product Registration and Renewal: What Companies Need to Know
Understand how the update of ANVISA’s guidelines affects the registration and renewal of smoking products and how QR Group can help in the process. ANVISA recently updated its guidelines on the registration and renewal of smoking products derived from tobacco. This change is included in the Collegiate Board Resolution (RDC) 896/2024, which reformulates the requirements […]
