QR Group Explains Data Sharing Agreement Between Anvisa and FDA
Understand how the new agreement between Anvisa and the FDA can speed up drug approval in Brazil and how QR Group can help your company comply. The National Health Surveillance Agency (Anvisa) and the Food and Drug Administration (FDA), the regulatory body in the United States, have signed an important confidentiality agreement that will facilitate […]
Simplifying the process: regularizing products at ANVISA
Understand the essential steps for regularizing products with ANVISA and how QR Group can help your company ensure compliance quickly and safely. If you work in the industry of products that require regularization with the health surveillance agency, you know that regularizing products with ANVISA is a crucial step, not only for marketing, but also […]
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 […]
Registering Medical Products in Brazil – What do you need to know?
Registering medical products in Brazil goes through ANVISA – the National Health Surveillance Agency – which is the agency responsible for approving the marketing of any product related to human health in Brazil. The agency divides products into categories, such as health products, cosmetics, cleaning products, medicines, food, cannabis products and tobacco. The first step […]
Anvisa Launches Consultation Panel for Active Ingredients of Medications with Drug Registration Process
New Anvisa Tool Brings Transparency to the Brazilian Drug Registration Process Anvisa has just made available an online dashboard that allows users to consult the active ingredients of drugs with registration requests still under analysis. The tool is an innovation that promotes transparency in the regulatory process, offering a detailed view of the different categories […]
Why is Good Manufacturing Practices Training Essential in Brazil?
QR Group Explains How Training Can Be a Competitive Advantage in the Healthcare Market In Brazil, where the healthcare sector is constantly evolving, companies that invest in good manufacturing practices stand out for the quality and safety of their products. QR Group, a specialist in regulatory consulting and product registration with ANVISA, reinforces the importance […]
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 […]
Anvisa Publishes English Version of IN 289/2024: Regulatory Convergence and Efficiency
How IN 289/2024 Facilitates the Registration and Post-Registration Process for Medicines and Biological Products in Brazil Anvisa has just released the English version of Normative Instruction (IN) 289/2024, reinforcing the agency’s commitment to international regulatory convergence. The new standard establishes procedures to streamline the registration and post-registration analysis of medicines, biological products, vaccines and Cadifas. […]
QR Group Reports: Anvisa Extends Participation Deadline in Pilot Project for Innovative Medical Devices
Understand how the extension of the deadline for the pilot project for regulatory evaluation of innovative medical devices impacts the healthcare sector and how QR Group can help. Anvisa has extended the deadline for submitting Innovative Medical Devices projects in the pilot project for regulatory evaluation, now with a deadline until January 19, 2024. This […]
