RDC 954/2024: Updates to the Simplified Drug Registration Procedure
Key Changes and Impacts for Drug Manufacturers The recent update of RDC 954/2024 brought significant changes to the simplified procedure for registering medicines in Brazil. In an exclusive event held by ANVISA on March 13, experts discussed the main guidelines and their impacts on the pharmaceutical sector. QR Group has closely followed the news to […]
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, […]
Anvisa Resumes Monitoring of Medical Device Prices: What Does This Mean for the Sector?
Transparency and Regulation: QR Group Explains the Resumption of Data Publication Anvisa has resumed the publication of medical device price monitoring data on its Business Intelligence (BI) dashboards. This activity, previously suspended due to the Agency’s internal restructuring, once again offers crucial information for the health sector. With this resumption, companies in the segment have […]
QR Group Analyzes the Debate on Regulation of Food Ingredients by Anvisa
Main Conclusions of Anvisa’s Sector Dialogue On 03/14, Anvisa held a virtual sector dialogue to discuss the regulation of food ingredient specifications, as defined by Project 3.8.1 of the 2024/2025 Regulatory Agenda. QR Group, a specialist in sanitary regulation, closely followed the discussions and highlights the main points addressed and their impacts on companies in […]
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 […]
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 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 […]
QR Group Explains CMED’s Targeted Consultation on Pricing of Advanced Therapies
Understand how CMED’s Directed Consultation impacts the advanced therapies market and how QR Group helps companies to adapt The Drug Market Regulation Chamber (CMED) published Call Notice 01/2025 in the Federal Official Gazette on February 7, inviting health professionals, pharmaceutical industries and other interested parties to participate in the consultation on the pricing of advanced […]
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 […]
