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 […]
Regularization of Cannabis-Based Products for Veterinary Use
Understand how the new measure impacts the regulation of veterinary products and how QR Group can help companies in the process. On October 30, ANVISA’s Collegiate Board approved a measure that allows the regularization of cannabis-based products for veterinary use by the Ministry of Agriculture and Livestock (MAPA). The decision amends Ordinance SVS/MS 344/1998, allowing […]
Elevidys® Approval by ANVISA: The Impact of Gene Therapy for Duchenne Muscular Dystrophy
Understand the Approval of Elevidys and How QR Group Assists® in the Registration Process of Innovative Products in Brazil The approval of Elevidys® (delandistrogen moxeparvoveque) by ANVISA for the treatment of Duchenne Muscular Dystrophy (DMD) represents a milestone in the area of advanced therapies in Brazil. QR Group, with its expertise in medical device and […]
QR Group Explains Anvisa’s New Rules for Importing Medical Device Components
Understand how the updates to RDCs 860/2024 and 939/2024 impact the import and storage of medical device components and accessories in Brazil Anvisa has updated the processes and flows related to the import and storage of medical device components. With the recent publication of Collegiate Board Resolutions (RDCs) 860/2024 and 939/2024, importers need to understand […]
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 […]
ANVISA’s Participation in WHO: Impacts on the Regulation of Medical Products
Understand the Importance of ANVISA’s Role in the Global Product Regulation ANVISA is participating in the 13th plenary meeting of the Member States Mechanism on Substandard and Falsified Medical Products (MSMSF) of the World Health Organization (WHO), reinforcing its essential role in product regulation at the international level. The event will take place between November […]
QR Group Explains the Impact of the Mais Médicos Program in Brazil
Understand how the Mais Médicos program is strengthening healthcare in Brazil, with 95% of vacancies filled by professionals trained in the country and the growing participation of quota holders The Mais Médicos program, which has reached its 38th cycle, continues to expand access to healthcare in Brazil, filling 95% of new vacancies with professionals trained […]
Challenges for companies and inspectors in interpreting the requirements of legislation and international standards of Health Surveillance
One of the biggest challenges for companies that manufacture or import/distribute health products is understanding and/or interpreting regulatory requirements, whether they are resolutions/legislation or international standards of the Health Surveillance Agency. The applicability of certain requirements in certain segments must be carefully assessed by both companies and authorities, which makes the inspection process by health […]
Spending on Medication Represents 33.7% of Brazilian Families Health Expenditure in 2021, According to IBGE
Understand how the Growth in Spending on Medication Impacts the Economy and QR Group’s Role in Access to Health Products In 2021, Brazilians spent R$168.3 billion on purchasing medications, representing 33.7% of household spending on healthcare, according to data from IBGE. This increase reflects both the impact of the pandemic and the aging of the […]
