Dear Colleagues, Last week, the Brazilian Patent and Trademark Office (BRPTO) opened a public consultation on Chapter 9 of the Guidelines for the Examination of Patent Applications in the Chemical Field (Rule No. 208/2017), which addresses claims directed to new uses...
Life Sciences
WIPO survey for biological sequences that complement patent applications
Dear Colleagues, As you may be aware, WIPO Standard ST.26 introduced a change regarding the minimum length requirement for nucleotide and amino acid sequences, namely, short sequences should not be considered to compose sequence listing files. The nucleotide sequences...
ANVISA seeks public input on a proposed resolution to enhance the monitoring of health risks and compliance in establishments manufacturing pharmaceutical supplies.
On December 23, 2024, the Brazilian Health Regulatory Agency (ANVISA) published Public Consultation No. 1.303, which aims to draw up a regulatory act with guidelines for managing health risks and monitoring companies' compliance. The proposal seeks the creation of a...
President Lula Signs Law 15.070/2024: Regulatory Framework for Bioinputs Boosts Sustaintabilty and Innovation in Brazilian Agriculture
New legislation regulates the bioinput chain, promotes sustainability and encourages innovation in Brazilian agribusiness. In an initiative that promises to transform national agriculture, President Luiz Inácio Lula da Silva sanctioned Law 15.070/2024,...
Senate Approves Regulatory Framework for Bioinputs in Brazil: A Milestone for Agricultural Sustainability
The Bioinputs Bill moves to presidential sanction, promising to transform agricultural practices in the country. Last Tuesday, the Federal Senate took a historic step by approving the Bioinputs Bill, which now awaits presidential sanction to become law. This...
ANVISA Innovates with Artificial Intelligence in Medication Analysis
In a pivotal step toward modernizing its medication evaluation processes, Brazil’s National Health Surveillance Agency (ANVISA) has implemented an artificial intelligence (AI) tool to streamline impurity qualification analyses in pharmaceuticals. This innovation aims...
ANVISA Establishes Technical Chamber for Clinical Research on Medicines and Medical Devices (Catepec)
ANVISA (the Brazilian Health Regulatory Agency) has announced a significant initiative for the healthcare sector: the creation of the Technical Chamber for Clinical Research on Medicines and Medical Devices, known as Catepec. With this new chamber, ANVISA aims to...
New MAPA Ordinance for Technical Products and Pesticides
On June 27, 2024, the Ministry of Agriculture and Livestock (MAPA) published Ordinance No. 1,136, dated June 25, 2024, which establishes guidelines for the rework, revalidation, and reprocessing of technical products, pre-mixtures, and pesticides. This measure aims to...
ANVISA Updates Food Expiry Guide with International References
The National Health Surveillance Agency (ANVISA) published the second version of the guide for determining the expiry dates of food products sold in Brazil on July 3. Developed based on international references, the document aims to enhance food safety standards in...
Brazil Establishes National Policy for the Conservation and Sustainable Use of Genetic Resources
New measure aims to preserve and sustainably use genetic resources, promoting food security and innovation Decree No. 12,097, dated July 3, 2024, established the National Policy for the Conservation and Sustainable Use of Genetic Resources for Food, Agriculture, and...
National Bioeconomy Strategy: A Pathway to Brazil’s Sustainable Future
In celebration of World Environment Day, on June 6, 2024, the Federal Government issued Decree No. 12,044/2024, which establishes the National Bioeconomy Strategy. This decree marks a significant step in coordinating and implementing public policies aimed at...
The Biotechnology Revolution with the New WIPO Treaty
The new WIPO treaty requires the disclosure of origins in patents and promotes the sharing of benefits related to the use of genetic resources and traditional knowledge. Global biotechnology is about to undergo a significant transformation with the recent approval of...
Brazil’s ANVISA Approves New Regulation for Biosimilar Drug Registration Simplifying the Development Process for Biosimilars
On May 27, ANVISA (Brazilian Health Regulatory Agency) approved a new regulation for the registration of biosimilar drugs, aiming to simplify and expedite their development. The new regulation introduces a more flexible approach to the requirements for developing...
MAPA Introduces Alternative to Sanctions for Agricultural Establishments
On April 15, the Ministry of Agriculture, Livestock and Food Supply (MAPA), through its Secretary for Agricultural Defense, published Ordinance 1.091/2024 in the Federal Official Gazette, which establishes criteria for establishments signing terms of commitment as an...
ANVISA establishes optimized procedure applications for registration of medical devices
On April 8th, the Brazilian health regulatory agency ANVISA published a Normative Instruction (290/2024), establishing the optimized procedure on the analysis and decision of applications for the registration of medical devices. As already mentioned in our earlier...