QR Group analyzes the main points of the proposal and advises companies on the regulatory impacts for registration and marketing in Brazil
ANVISA Opens Public Consultation to Update Rules for Medical Cannabis Products In July 2025, ANVISA opened a new Public Consultation to update RDC No. 327/2019, which currently regulates cannabis products for medical use in Brazil. The initiative aims to review technical and operational criteria to keep up with scientific evolution, ensure greater regulatory certainty, and […]
CMED Initiates Dialogue on Review of Drug Pricing Rules
QR Group analyzes the impacts of the proposal on the pharmaceutical sector and how companies can prepare for the new regulatory scenario The Drug Market Regulation Chamber (CMED), linked to ANVISA, announced in July 2025 the start of a structured dialogue with the regulated sector to discuss the revision of drug pricing rules in Brazil. […]
ANVISA Cancels In Vitro Medical Devices That Failed to Meet Reclassification Deadline
QR Group warns of the impact of non-compliance with the requirements of RDC 36/2015 and guides companies on how to keep their records in compliance In July 2025, ANVISA announced the cancellation of registrations of medical devices for in vitro diagnosis (IVD) that did not meet the deadline for sanitary reframing, established by RDC No. […]
QR Group Explica as Mudanças na RDC 954/2024 e Seu Impacto no Registro de Medicamentos
New ANVISA resolution updates criteria for simplified registration and brings greater clarity to the regulatory process With official publication in April and expected to come into force in October 2024, RDC No. 954/2024 brings an important update to the drug registration process with ANVISA. The new rule repeals RDC No. 199/2006 and redefines the criteria […]
RDC 954/2024 Updates Simplified Medication Registration
QR Group analyzes the impacts of ANVISA’s new rule and guides companies on how to adapt to changes in the regularization process ANVISA published RDC No. 954/2024, which updates the criteria and procedures for the simplified registration of medicines. The new rule repeals the old RDC No. 199/2006 and comes into force as of October […]
ANVISA Defines Priority Foreign Regulatory Authorities
QR Group analyzes how the strategy strengthens regulatory trust and facilitates the registration of health products in Brazil In 2024, ANVISA released the list of priority foreign regulatory authorities to strengthen the process of regulatory trust in Brazil. The measure is part of the agency’s regulatory agenda and aims to streamline analysis and decisions through […]
QR Group analyzes the impacts of digitalization on toxicological risk assessment and registration processes in Brazil
ANVISA Implements New Tool for Toxicological Evaluation of Pesticides ANVISA announced the implementation of a new computerized tool for toxicological evaluation of pesticides, with the objective of modernizing and speeding up the technical analysis of these products. The solution integrates a set of functionalities that allow the agency to more efficiently process the data sent […]
ANVISA Begins Review of RDC 81/2008: Impacts on Imported Products
QR Group analyzes the effects of the proposal to update the main rule that regulates the import of products subject to health surveillance in Brazil In 2024, ANVISA began the process of revising RDC No. 81/2008, a rule that for more than 15 years has established the requirements for importing products subject to health surveillance, […]
CMED Opens Directed Consultation on Pricing of Advanced Therapies
QR Group analyzes regulatory impacts and what companies need to consider in the commercialization of gene, cell and tissue therapies The Drug Market Regulation Chamber (CMED) has started a targeted consultation on the pricing of advanced therapies — such as gene, cell, and tissue therapies. The measure aims to receive contributions from the regulated sector, […]
ANVISA Receives Top Score for Good Regulatory Practices
QR Group analyzes the impact of agency performance for companies seeking registration of health products in Brazil ANVISA was rated 10 in the OECD Index of Good Regulatory Practices, according to a report released in April 2024. The index, prepared by the Organization for Economic Cooperation and Development, measures the quality of standard-making processes in […]
