The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (1977) establishes an international regime for the recognition of microorganism deposits for patent purposes in any ´International Depository...
Life Sciences
The National Strategy for the Development of the Economic-Industrial Health Complex (CEIS) and Partnerships for Productive Development (PDPs)
Since the beginning of this year, the Federal Executive has been working, led by the Executive Group of the Economic-Industrial Health Complex (GECEIS) – established by Decree 11,464/2023, to strengthen the domestic production of essential items for the Unified Health...
New Form for Indicating Agricultural Pesticides for Toxicological Safety Reevaluation
On September 29, 2023, ANVISA announced the availability of a new form for indicating agricultural pesticides to undergo reevaluation for their toxicological safety. It is important to note that technical and scientific information supporting the indication must be...
ANVISA’s Innovation Policy Established by Ordinance 1,100/2023
On October 2, 2023, Ordinance 1,100/2023 was published, establishing ANVISA's Innovation Policy. This measure aims to enhance the agency's ability to address complex and unforeseen challenges while promoting the development and adoption of innovative products and...
Public Consultation for the Modification of the Biosimilars Regulation
On October 4, 2023, ANVISA published Public Consultation 1,206/2023 regarding the amendment of the current biosimilar drug regulation. This Public Consultation was approved during a meeting of ANVISA´s Collegiate Board (DICOL) held on September 27, 2023, with the aim...
Provisional Ruling enacted addressing measures for controlling phytosanitary and zoosanitary emergencies
The Federal Government issued yesterday Provisional Ruling 1,186/2023, which supplements Law 12,873/2013 with important tools to ensure that the country effectively addresses phytosanitary or zoosanitary emergencies. The new legislation grants authority to the bodies...
Brazil to provide new framework on telehealth
According to a recent study, the global telehealth market grew to USD 144,38 billion in 2020, which represents growth of 135.2% on the 2019 average. In Brazil, revenue in the digital health market (including different technologies such as health apps, wearable...
Brazilian PTO annuls patent for CBD based drug
In a decision published on 27 July, the Brazilian PTO annulled the patent for the drug Myalo, a CBD based medicine marketed by the company Prati-Donaduzzi. As discussed in our previous article on the subject of Patents for Cannabis Products in Brazil, Prati-Donaduzzi...
The role of ANVISA in cannabis related patents
As mentioned in our previous post on this topic, patent applications for pharmaceutical products or processes must be submitted to ANVISA (The Brazilian Health Surveillance Agency) for prior consent based on a public health analysis. The government lists many...