Brazil: Food and Drugs Law

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BRPTO Announces Collaborative Examination Program With INDECOPI
The Brazilian Patent and Trademark Office (BRPTO) and Peru's INDECOPI have launched a collaborative examination initiative for patent applications in pharmaceuticals, biotechnology, and natural products. This partnership, formalized through a 2025 Bilateral Cooperation Memorandum, will provide expedited technical examination for qualifying PCT applications that entered the national phase between October 2022 and July 2023.
Brazil IP
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Article
Primeiras impressões da nova lei das PDPs: Disposições confusas e risco de reserva de mercado
A lei 15.471/26 instituiu a Estratégia Nacional de Saúde do Complexo Econômico-Industrial da Saúde (ENSCEIS), conferindo status legal a políticas anteriormente baseadas apenas em atos infralegais. Embora represente avanços ao consolidar programas como as Parcerias para o Desenvolvimento Produtivo (PDPs), a nova legislação apresenta falhas de clareza, insegurança jurídica em disposições importantes e riscos de criar reservas de mercado que podem pos
Brazil Healthcare
LA
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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
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