South America: Food, Drugs, Healthcare, Life Sciences

Regulatory updates from ANVISA, CFM, and CFF shape strategic decisions across pharmaceutical, medical device, and supplementary health sectors. This edition covers key regulatory movements affecting strategic sectors including pharmaceutical industry, supplementary health, food products, and other regulated products, including cases involving regulatory interface with ANVISA and professional councils.

Biocon Limited has partnered with Brazilian companies Bahiafarma and Bionovis to secure an exclusive ten-year supply contract for its pertuzumab biosimilar in Brazil's public healthcare market. The partnership aims to improve access to this HER2-positive breast cancer treatment while reducing costs and developing Brazil's domestic pharmaceutical manufacturing capabilities through phased localization.

Chile's Public Health Institute has issued new requirements mandating pharmaceutical companies to submit digitized versions of their Professional Information Leaflets for publication on the ISP website. Marketing authorization holders must comply with specific formatting and submission procedures by December 31, 2026, or face potential administrative proceedings and sanctions.