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 […]
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 […]
