Brazil: Healthcare

Brazil's Ministry of Health is advancing the regulatory framework for the National Health Strategy for the Health Economic-Industrial Complex (ENSCEIS), established by Statute #15,471 of July 20, 2026. The framework aims to strengthen domestic production and innovation capacity in the health sector while reducing dependence on foreign technology and expanding access to strategic health technologies for Brazil's public healthcare system.

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.

Explore the latest regulatory updates impacting Brazil's pharmaceutical, healthcare, cosmetics, and medical device industries in June. From ANVISA's new pharmacovigilance system to CFM's platform against medical practice violations, discover how these changes create both compliance challenges and strategic opportunities for industry stakeholders.

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The Brazilian Federal Council of Medicine has issued Resolution CFM No. 2,462/2026, establishing administrative measures against legal entities that fail to remunerate physicians for services rendered. This regulation expands the supervisory power of Medical Councils and introduces significant compliance obligations for hospitals, cooperatives, social organizations, and other entities involved in contracting or intermediating medical services, with penalties ranging from warnings to registration cancellatio

Few fields of innovation are as labor-intensive or impactful as pharmacy. While groundbreaking new drugs grab headlines...

A nova resolução do Conselho Federal de Medicina estabelece novos procedimentos para a declaração de vínculos profissionais...

The new Federal Council of Medicine resolution introduces updated procedures for declaring professional relationships, aiming to enhance transparency and safeguard the interests of patients and society...