Anvisa and USP sign new Memorandum of Understanding for health regulations.
Fortalecimento da Cooperação Regulatória entre Brasil e EUA A Agência Nacional de Vigilância Sanitária (Anvisa) e a Farmacopeia Americana (United States Pharmacopeia – USP) assinaram um novo Memorando de Entendimento, consolidando uma parceria iniciada em 2016. O acordo, com vigência de cinco anos, visa ampliar a colaboração técnica e científica, fortalecendo a regulação sanitária no […]
QR Group Explains the Changes in RDC 954/2024 and Its Impact on Drug Registration
Understand How the Changes in RDC 954/2024 Impact Drug Registration and How QR Group Assists International Manufacturers With the entry into force of RDC 954/2024, the drug registration process undergoes significant changes. The rule revises and simplifies the regulatory procedure, promoting greater speed in the registration, post-registration and renewal processes. QR Group, a specialist in […]
RDC 954: Simplified Registration of Medications and Its Impacts
ANVISA Event Details Changes in RDC 954/2024 On March 13, ANVISA held an exclusive event on RDC 954/2024, which brings important updates to the simplified registration of medicines. The high demand for face-to-face participation led to the opening of online transmission, allowing a greater number of professionals to follow the changes in real time. QR […]
ANVISA Selects Priority Foreign Authorities to Strengthen Regulatory Confidence
Impact for Medical Device and Drug Manufacturers The National Health Surveillance Agency (ANVISA) approved, at a meeting of the Committee for Strategic Management, Risks and Institutional Innovation (CGE), the list of priority Foreign Regulatory Authorities. This decision aims to consolidate regulatory trust (“reliance”), accelerating registration and inspection processes of medicines and medical devices in Brazil. […]
Anvisa Implements Tool to Speed Up Toxicological Assessment of Pesticides
New rule optimizes analysis of petitions and reinforces security in pesticide regulation As of January 2, 2025, Anvisa’s Collegiate Board Resolution (RDC) 950/2024 comes into force, establishing complementary requirements to optimize the toxicological evaluation of pesticides formulated from equivalent technical products. The measure aims to make processes more efficient, maintaining scientific rigor and ensuring safety […]
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 […]
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 […]
