Brazil: Healthcare

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Article
Legal Landscapes: Brazil- Life Sciences
Brazil's Life Sciences legal landscape is undergoing significant transformation through regulatory consolidation, pricing reforms, and evolving IP frameworks. Recent Supreme Court decisions on patent extensions and healthcare judicialization, combined with stricter CMED pricing controls, are reshaping market access strategies and creating both challenges and opportunities for pharmaceutical and biotech companies operating in this complex regulatory environment.
Brazil Healthcare
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Article
CMED Updates Rule On Drug Pricing
Brazil's Drug Market Regulation Chamber has introduced significant modifications to its drug pricing framework through Rule #7/2026, adjusting criteria for new drugs, biosimilars, and generic medications. The regulatory changes simplify documentation requirements for biosimilars while clarifying provisions for generic drug pricing, though several industry concerns regarding off-label treatment comparisons and retroactive application remain unresolved.
Brazil Healthcare
LA
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