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 […]
Anvisa Prioritizes Registration of Tests for Arboviruses, Including Dengue and Chikungunya
Anvisa is implementing measures to speed up the registration of diagnostic tests for mosquito-borne diseases, aiming at better control of arboviruses in Brazil. The National Health Surveillance Agency (Anvisa) recently announced that it will prioritize the analysis of requests for registration of tests for the diagnosis of mosquito-borne diseases, such as dengue, chikungunya and oropouche […]
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 […]
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 […]
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. […]
