06/10/2026
On October 5, 2026, Anvisa published RDC No. 1,045/2026, regulating Article 27, §2 of Law No. 6,360/1976, as amended by Law No. 15,154/2025, and establishing a simplified sanitary framework for artisanal personal care products, cosmetics, and perfumes. The regulation will enter into force 60 days after its publication, providing the sector with a transition period …
18/06/2026
Technical Note defends the safety of multiple switching between the comparator (reference) biological drug and its biosimilars. This understanding also extends to multiple switches performed between biosimilars of the same comparator biological drug. On June 11, 2026, it was published Technical Note No. 60/2026, issued by Anvisa through its General Management of Biological Products, Radiopharmaceuticals, …
09/06/2026
The Genetic Heritage Management Council (CGen) will hold its 45th Ordinary Meeting on June 10 and 11, 2026, to discuss developments concerning SisGen (system for registering access to genetic heritage and associated traditional knowledge) and proposals for regulatory adjustments with potentially relevant impact on regulated sectors. The main topics are outlined below. Harmonization of the …
05/06/2026
Summary. The Secretariat of Prizes and Betting of the Ministry of Finance (SPA/MF) has issued Technical Note SEI No. 3620/2026, dated June 3, 2026, addressed to authorized fixed-odds betting operators, concerning communication, advertising and marketing activities during the 2026 FIFA World Cup (June 11 to July 19, 2026). The Note does not create new obligations, …
09/04/2026
A Receita Federal do Brasil publicou, em 26 de março de 2026, a Instrução Normativa RFB nº 2.318/2026, que reformula o Programa Brasileiro de Operador Econômico Autorizado (OEA). Poucos dias depois, em 7 de abril de 2026, foi publicada a Portaria Coana nº 187/2026, responsável por detalhar e viabilizar sua aplicação prática, a partir da …
06/04/2026
Public Consultation No. 1/2026 has been published by the National Research Ethics Authority (Instância Nacional de Ética em Pesquisa – “INAEP”), inviting public participation on the proposed new guidelines applicable to biobanks of human biological material, within the scope of the National System for Research Ethics Involving Human Beings (Sistema Nacional de Ética em Pesquisa …
11/03/2026
The Second Panel of the Federal Supreme Court (STF) unanimously denied the internal appeal filed by the Brazilian Federal Court of Accounts (TCU) and fully reinstated the legal effect of ANTAQ Resolution No. 72/22, reaffirming the possibility of charging the Container Segregation and Delivery Service (SSE). The controversy centered on the actions of the TCU, …
04/02/2026
As 2026 begins, companies regulated by Brazilian Health Regulatory Agency (Anvisa), the National Supplementary Health Agency (ANS), and the Ministry of Agriculture and Livestock (MAPA) face a dynamic regulatory landscape. To support organizations in anticipating risks and preparing for strategic decision‑making, our Life Sciences & Healthcare team has identified 17 regulatory topics that will shape …
08/01/2026
On January 8, 2026, the Brazilian Drug Market Regulation Chamber (CMED) published in the Federal Register the Public Consultation No. 1/2026, which aims to gather contributions from civil society and the regulated sector on criteria for setting and adjusting prices of medicines sold to government entities to comply with court-ordered demands. The regulation of this …
29/12/2025
On December 24, 2025, the Brazilian Drug Market Regulation Chamber (“CMED”) published Resolution 3/2025 in the Federal Register, establishing criteria for the definition of prices for new products and new presentations of medicines, as provided in Article 7 of Law 10,742/2003, and setting out the procedure for filing the Price Information Document (“DIP”). Resolution 3/2025was …