https://www.bioworld.com/rss en-us Gemma Biotherapeutics Inc.’s GB-221, a novel gene therapy for spinal muscular atrophy type 1 (SMA1), has received clinical trial clearance from ANVISA, Brazil’s health regulatory agency. http://www.bioworld.com/articles/726546 Tue, 25 Nov 2025 08:00:00 -0500 https://www.bioworld.com/articles/726546-gemmas-gb-221-gains-trial-clearance-in-brazil-for-sma1 Regulatory reliance is all the rage of late, but some nations employ a four-tier risk classification scheme while others use a three-tier scheme. http://www.bioworld.com/articles/719416 Thu, 24 Apr 2025 12:00:00 -0400 https://www.bioworld.com/articles/719416-differences-in-risk-classification-schema-not-necessarily-a-bar-on-reliance World with digital overlay Anvisa launched a pilot program to help Brazilian biopharma startups navigate the regulatory path from the initial phases of product development. In addition to providing regulatory support, the goal of the program is to accelerate the process of drug innovation in the country. http://www.bioworld.com/articles/707509 Wed, 10 Apr 2024 12:00:00 -0400 https://www.bioworld.com/articles/707509-anvisa-pilot-program-to-spur-biopharma-innovation-in-brazil To help drug manufacturers comply with the technical requirements of RCD 753/2022 and other related standards regarding proof of a drug’s safety and efficacy, Brazil’s Anvisa issued three new guidelines for submitting registration requests for new or innovative synthetic and semi-synthetic drugs. http://www.bioworld.com/articles/695810 Tue, 04 Apr 2023 12:00:00 -0400 https://www.bioworld.com/articles/695810-anvisa-issues-guidelines-for-synthetic-drugs Brazil’s health care regulator plans to start enforcing in July new regulations for software as a medical device (SaMD), clearing up doubts about its oversight over intangible health care assets such as software. http://www.bioworld.com/articles/519257 Fri, 27 May 2022 13:00:00 -0400 https://www.bioworld.com/articles/519257-brazil-readies-to-adopt-samd-regulation Brazilian flag Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote. http://www.bioworld.com/articles/510533 Tue, 17 Aug 2021 16:16:00 -0400 https://www.bioworld.com/articles/510533-celltrion-wins-anvisa-approval-for-covid-19-antibody-in-first-nod-outside-asia Celltrion-Regkirona-2-9 Credit: Celltrion Inc. Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote. http://www.bioworld.com/articles/510376 Thu, 12 Aug 2021 12:00:00 -0400 https://www.bioworld.com/articles/510376-celltrion-wins-anvisa-approval-for-covid-19-antibody-in-first-nod-outside-asia Celltrion-Regkirona-2-9 Credit: Celltrion Inc. For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency, and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices. http://www.bioworld.com/articles/507147 Mon, 17 May 2021 12:00:00 -0400 https://www.bioworld.com/articles/507147-brazilian-and-european-regulators-agree-to-share-confidential-information Handshake behind digital globe For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency (EMA), and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices. http://www.bioworld.com/articles/507107 Fri, 14 May 2021 13:00:00 -0400 https://www.bioworld.com/articles/507107-brazilian-and-european-regulators-agree-to-share-confidential-information Handshake behind digital globe COLOMBIA – South Korea’s molecular diagnostics firm Seegene Inc. is expanding operations in the Brazilian market after Anvisa, the country's health care surveillance agency, cleared its multi-assay product through a COVID-19 emergency pathway. Seegene manufactures Allplex, a SARS-CoV-2/FluA/FluB/RSV test able to screen and differentiate eight targets. http://www.bioworld.com/articles/503583 Fri, 12 Feb 2021 13:00:00 -0500 https://www.bioworld.com/articles/503583-seegene-strengthens-footprint-in-latin-america-via-covid-testing Mask with Brazilian flag CAJICA, Colombia – Brazil’s health care surveillance agency, Anvisa, granted the first two emergency approvals for COVID-19 vaccines on Sunday, Jan. 17, giving the green light to Sinovac Biotech Ltd.’s Coronavac and to Covishield, developed by Astrazeneca plc and the University of Oxford. http://www.bioworld.com/articles/502558 Tue, 19 Jan 2021 12:00:00 -0500 https://www.bioworld.com/articles/502558-brazil-approves-coronavac-and-covishield-covid-19-vaccines-turns-sputnik-v-back Woman gets COVID-19 vaccine in Brazil Mônica Calazans, a 54-year-old nurse in Sao Paulo, receives the first Coronavac vaccine shot after Anisa’s approval. Governor of Sao Paulo, Joao Doria, oversees the procedure. Credit: Government of Sao Paulo. Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals. http://www.bioworld.com/articles/501024 Mon, 07 Dec 2020 12:00:00 -0500 https://www.bioworld.com/articles/501024-brazils-anvisa-issues-emergency-pathway-for-covid-19-vaccines-though-some-firms-seek-other-routes Coronavac shipment Joao Doria, governor of the state of Sao Paulo, Brazil, along with his staffers at the Guarulhos International Airport, receives a shipment of 1 million doses of Coronavac, manufactured by Sinovac Biotech, from Beijing, China, on Dec. 3. Photo: Joao Doria's Twitter. CAJICA, Colombia – Chembio Diagnostic Systems Inc., a point-of-care diagnostic company focused on infectious diseases, received the approval from Anvisa, the Brazilian health care surveillance agency, to distribute its tests in the Latin American market. The approval adds yet another test to the hundreds already approved in Brazil, where the market for such tests is quickly getting crowded sending prices down. Brazil is one of the countries most affected by COVID-19 with almost 6 million cases and 166,000 deaths, the third highest number of cases in the world. http://www.bioworld.com/articles/500869 Wed, 02 Dec 2020 13:00:00 -0500 https://www.bioworld.com/articles/500869-chembio-looks-for-share-of-competitive-brazilian-market-for-sars-cov-2-tests Novel coronavirus SARS-CoV-2 Transmission electron micrograph of a SARS-CoV-2 virus particle, isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility in Fort Detrick, Maryland. Credit: NIAID The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIST ramps up Zero Trust cybersecurity program; TGA sets date for mesh up-classification; IMDRF posts post-market study update; ANVISA updates list of non-regulated devices. http://www.bioworld.com/articles/499217 Tue, 20 Oct 2020 12:00:00 -0400 https://www.bioworld.com/articles/499217-fda-adds-to-roster-of-reg-science-tools CAJICA, Colombia – In a move to reduce bureaucratic procedures and fight backlogs, the Brazilian health care surveillance agency, Anvisa, softened its rules for the marketing authorization of class II medical devices in the Latin American country. http://www.bioworld.com/articles/498747 Thu, 08 Oct 2020 13:00:00 -0400 https://www.bioworld.com/articles/498747-cutting-the-red-tape-brazil-eases-class-ii-registration Brazilian flag http://www.bioworld.com/articles/679462 Thu, 03 Sep 2020 00:00:00 -0400 https://www.bioworld.com/articles/679462-repavid-19-study-of-reparixin-in-severe-covid-19-pneumonia-approved-in-brasil PARIS – The Cour des comptes, supreme body for auditing the use of public funds in France, independent from government and parliament, has just released its report on the operation of the French National Agency for the Safety of Medicines and Health Products (ANSM). Following 10 months of administrative and financial investigation, these financial controllers have highlighted the weakness of controls applied to medical devices placed on the market in France. http://www.bioworld.com/articles/432322 Fri, 10 Jan 2020 12:00:00 -0500 https://www.bioworld.com/articles/432322-control-of-medical-devices-in-france-severely-criticized-by-the-cour-des-comptes French flags on building BOGOTA, Colombia – Last month, Anvisa, Brazil's health surveillance agency, approved a proposal that makes it mandatory for the agency to monitor the prices of medical implants, a category that, in Brazil, includes orthoses, prostheses and special materials. Is this the beginning of a price capping era for medical devices in the Latin American giant? http://www.bioworld.com/articles/430508 Tue, 24 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/430508-is-brazil-moving-toward-a-med-tech-price-cap SAO PAULO, Brazil – Latin America is rife with opportunities to undertake clinical trials, but regulatory adjustments are needed for companies to fully take advantage of them. As the largest market in the region, Brazil, for one, is in dire need of those adjustments, said experts gathered in Sao Paolo last week for the annual BIO Latin America conference. http://www.bioworld.com/articles/429389 Thu, 12 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/429389-latam-region-should-improve-clinical-trial-regulation-experts http://www.bioworld.com/articles/663076 Fri, 29 Dec 2017 00:00:00 -0500 https://www.bioworld.com/articles/663076-brazilian-approval-for-biocon-and-mylan-s-trastuzumab-biosimilar