08/10/2026
The National Research Ethics Authority (INAEP, in Portuguese), together with Brazil’s Ministry of Health, has launched a public webpage to provide updates on the development of the new National Clinical Research Platform, a system that is expected to gradually replace Plataforma Brasil and operationalize the new governance framework established under Law No. 14,874/2024. The initiative …
02/10/2026
The National Research Ethics Authority (INAEP) has issued its Technical Guidance on Single Ethical Review for Multicenter Research, providing important clarifications regarding the implementation of Brazil’s new clinical research regulatory framework. The document comes amid ongoing discussions among regulatory authorities, sponsors, CROs, research institutions, and Research Ethics Committees (RECs) concerning operational questions that remained following …
02/10/2026
The National Research Ethics Authority (INAEP) has taken another significant step in consolidating Brazil’s new regulatory framework by publishing a set of documents addressing the use of artificial intelligence (AI) in scientific research. These initiatives seek to promote greater legal certainty, regulatory predictability, and protection of research participants in light of the growing use of …
18/09/2026
As anticipated in our update of September 14, 2026, the CGEN (Genetic Heritage Management Council) discussed and approved a resolution that will bring SisGen 3.0 into operation. This version of the National System for the Management of Genetic Heritage and Associated Traditional Knowledge will allow the registration of access to genetic heritage and associated traditional …
14/09/2026
At its next meeting, to be held on September 15 and 16, CGEN, the Genetic Heritage Management Council, will discuss a resolution that would bring SisGen 3.0 into operation. This version of the National System for the Management of Genetic Heritage and Associated Traditional Knowledge will allow the registration of access to genetic heritage and …
24/08/2026
On August 11, 2026, Federal Representative Adriana Ventura (Novo/SP), a member of the Committee on Industry, Trade and Services of the Chamber of Deputies, submitted substitute text and a favorable opinion on Bill No. 5810/2025, which seeks to establish a Patent Term Adjustment (PTA) to provide an additional term of patent protection in cases where …
11/08/2026
According to a decision published in the Industrial Property Gazette of August 11, 2026, INPI (the Brazilian Patent and Trademark Office) selected nine patent applications to launch its Collaborative Examination Project for Patent Applications with Indecopi (the Peruvian patent office). The project arises from the Memorandum of Understanding on Bilateral Cooperation signed by the two …
20/07/2026
The INPI (Brazilian Patent and Trademark Office) published on July 7th, 2026 INPI/PR Normative Ordinance No. 81, dated July 1, 2026. This ordinance updates the Regulatory Agenda of the INPI for the 2026–2028 period and becomes effective on the date of its publication. Under the section covering matters to be developed through public calls for …
03/07/2026
On Tuesday, June 30, 2026, INPI (Brazilian Patent and Trademark Office) published Normative Ordinance INPI/PR No. 80, dated June 29, 2026, updating the Examination Guidelines for Patent Applications in the Field of Chemistry regarding the chapter on new uses of known products. Given the importance of the subject, we present a structured summary below: 1. …
29/06/2026
In June, INPI (National Institute of Industrial Property), the Brazilian Patent and Trademark Office, published a document prepared by its technical staff proposing updates to the Industrial Property ACT (Law No. 9.279/1996) – which was enacted 30 years ago. After analysing internal proposals and those from the Interministerial Group on Intellectual Property (GIPI)—a group bringing …