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, […]
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, […]
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 […]
