Registration of access to genetic heritage and associated traditional knowledge by foreign entities will be possible beginning in December 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 knowledge carried out by foreign entities. This has long been a request of the industry, which, since the enactment of the Biodiversity Law (Law No. 13,123/2015), has awaited the possibility of regularizing activities conducted while Provisional Measure No. 2,186-16 was in force, as well as registering activities conducted under the current legislation. 

Under the approved resolution, SisGen 3.0 will be made available for a 60-day user familiarization period beginning on October 1, 2026. The regularization deadlines established by Decree No. 8,772/2016 will only begin to run on December 1, 2026, when the final version, with all new modules available and operational, will be released. 

Our Life Sciences & Healthcare team is available to provide any further clarification.