09/10/2025
On October 8, 2025, Decree No. 12,651/2025 came into force, regulating Law No. 14,874/2024 and establishing the National System of Ethics in Research with Human Subjects (SNEP). The regulation consolidates guidelines for ethical approval, governance, and accreditation of Institutional Review Boards (IRBs, known as CEPs in Portuguese), bringing greater legal certainty to the sector. Topics …
01/08/2025
On July 31, 2025, the President of Brazil sanctioned Law No. 15.183/2025 (originating from Bill No. 3,062/2022), which prohibits the use of live vertebrate animals in testing ingredients or finished products intended for personal care, cosmetics, and perfumes. The new law amends Law No. 11,794/2008 (the “Arouca Law”) and Law No. 6,360/1976, establishing new regulatory …
31/07/2025
Em 29 de julho de 2025, foi publicada a Lei Complementar nº 216, que institui o Programa Acredita Exportação e altera diversos dispositivos legais, com impactos significativos para empresas exportadoras, especialmente para as micro e pequenas empresas optantes pelo Simples Nacional e para as empresas beneficiárias dos regimes Recof e drawback. Entre as principais alterações …
09/07/2025
On July 2, 2025, the Brazilian Federal Senate approved the United Nations Convention on International Settlement Agreements Resulting from Mediation, known as the Singapore Convention on Mediation (PDL 228/2024). For the Convention to enter into force in Brazil, it must now be promulgated by the President of the Republic — a formal act that will …
07/07/2025
On July 2, 2025, the Presidency of the Republic published in the Official Gazette of the Union (DOU) the promulgation of the vetoed provisions of Law No. 14,874, dated May 28, 2024, marked as the Clinical Trial Law. On June 17, the National Congress overturned the President’s 2024 vetoes. Promulgated Provisions: Article 24, §3 – Requires that the participation of indigenous group members in research be reported to the …
23/06/2025
The Department of Genetic Heritage at the Ministry of the Environment and Climate Change (DPG/MMA) has launched a test environment for the new National Genetic Heritage and Associated Traditional Knowledge Management System (SisGen) module dedicated to non-Brazilian institutions, in order to make it possible to register its activities involving access to Brazilian genetic heritage in partnership …
23/06/2025
How are the 2025 predictions materializing? At the beginning of the year, our Life Sciences & Healthcare team presented a comprehensive overview of the main trends that would shape the sector regulated by Anvisa and ANS in 2025, which you can find here. Now, several months later, it is time to examine the present and …
18/06/2025
In a highly significant move for the clinical trial sector in Brazil, the National Congress has made a decision that could directly impact the future of scientific innovation and access to experimental treatments in the country. The overturning of the presidential veto on the Clinical Trial Law marks a new chapter in the regulation of …
12/05/2025
On May 5, 2025, Public Consultation 1,330/2025 of the Brazilian Drug Market Regulation Chamber (CMED) was published in the Federal Register, opening a 60-day period for submitting comments on the text of the proposed revision of CMED Resolution 02/2004, which deals with the criteria for defining prices of new products and new presentations of medicines. …
30/04/2025
A partir de 26 de maio de 2025, riscos psicossociais — como assédio moral e sexual, síndrome de burnout, carga excessiva de trabalho e fragilidades na comunicação e gestão — passam a ser reconhecidos oficialmente como fatores que impactam a saúde e segurança do trabalhador, ao lado dos já tradicionais riscos físicos, químicos, biológicos e ergonômicos. …