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 […]
New Import Payment Flow: What Has Changed and How It Impacts the Medical Devices Sector
ANVISA Webinar Presents Changes in the Import Process On March 17, ANVISA held a webinar to clarify the new payment flow of the health product import process. The main novelty is the integration of the ANVISA Fee into the Centralized Foreign Trade Payment (PCCE) module of the Single Foreign Trade Portal (Siscomex). The measure aims […]
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 […]
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 […]
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 […]
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 […]
