{"id":78411,"date":"2025-01-15T14:59:13","date_gmt":"2025-01-15T19:59:13","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=78411"},"modified":"2025-01-19T16:37:15","modified_gmt":"2025-01-19T21:37:15","slug":"biotalys-provides-regulatory-review-update-on-evoca","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/agrochemicals\/fungicides\/biotalys-provides-regulatory-review-update-on-evoca\/","title":{"rendered":"Biotalys fornece atualiza\u00e7\u00e3o de revis\u00e3o regulat\u00f3ria sobre EVOCA"},"content":{"rendered":"<p><a href=\"https:\/\/www.biotalys.com\/\" target=\"_blank\" rel=\"noopener\">Biotalys<\/a>, uma empresa de Tecnologia Agr\u00edcola (AgTech) que desenvolve solu\u00e7\u00f5es de biocontrole baseadas em prote\u00ednas para prote\u00e7\u00e3o sustent\u00e1vel de culturas, fornece hoje uma atualiza\u00e7\u00e3o sobre o processo de revis\u00e3o regulat\u00f3ria de seu primeiro biofungicida, EVOCA, na Europa e nos Estados Unidos.<\/p>\n<h2>Uni\u00e3o Europeia<\/h2>\n<p>A Biotalys tem o prazer de anunciar que a autoridade reguladora holandesa, CTGB (College voor de Toelating van Gewasbeschermingsmiddelen en Biociden), forneceu \u00e0 empresa seu Relat\u00f3rio de Avalia\u00e7\u00e3o de Rascunho inicial, recomendando a aprova\u00e7\u00e3o do ingrediente ativo do EVOCA em toda a Uni\u00e3o Europeia. O CTGB agora enviar\u00e1 seu relat\u00f3rio de rascunho ao Instituto Holand\u00eas de Sa\u00fade e Meio Ambiente (RIVM) para poss\u00edveis contribui\u00e7\u00f5es sobre requisitos de classifica\u00e7\u00e3o, rotulagem e embalagem, resultando no encerramento da primeira fase da revis\u00e3o regulat\u00f3ria do EVOCA na Europa.<\/p>\n<p>O CEO da Biotalys, Kevin Helash, disse: \u201cEste \u00e9 um marco significativo na jornada regulat\u00f3ria para nosso primeiro biocontrole, e vemos isso como uma grande vit\u00f3ria para nossa equipe. O CTGB tem ampla experi\u00eancia na avalia\u00e7\u00e3o de biocontroles, e estamos muito satisfeitos com sua recomenda\u00e7\u00e3o para aprova\u00e7\u00e3o, pois acreditamos que isso valida o potencial de nossa inovadora plataforma de tecnologia AGROBODY\u2122 para o desenvolvimento de novas solu\u00e7\u00f5es de biocontrole para produtores. Embora o processo de revis\u00e3o seja longo e ainda haja muito trabalho a ser feito, ganhar o apoio do regulador em um dos maiores pa\u00edses exportadores de frutas e vegetais do mundo \u00e9 um sinal de confian\u00e7a em nossa tecnologia. Estamos ansiosos para receber nossa primeira aprova\u00e7\u00e3o regulat\u00f3ria completa na Europa.\u201d<\/p>\n<p>Na pr\u00f3xima fase, a Autoridade Europeia para a Seguran\u00e7a Alimentar (EFSA) e os estados-membros da UE realizam revis\u00f5es aprofundadas do dossi\u00ea e fornecem feedback ao CTGB, permitindo ao mesmo tempo que a Biotalys entregue certos dados solicitados pelo CTGB. Espera-se que esta pr\u00f3xima fase leve no total entre 12 e 18 meses e tamb\u00e9m inclui uma consulta p\u00fablica, terminando com uma vota\u00e7\u00e3o dos estados-membros europeus sobre a aprova\u00e7\u00e3o do ingrediente ativo a n\u00edvel da UE.<\/p>\n<p>O rascunho do relat\u00f3rio de avalia\u00e7\u00e3o do CTGB segue sua decis\u00e3o recente, pela qual a autoridade aprovou testes de demonstra\u00e7\u00e3o em larga escala do EVOCA em estufas, permitindo, ao mesmo tempo, que as frutas e vegetais colhidos fossem vendidos para consumo humano.<\/p>\n<h2>Estados Unidos<\/h2>\n<p>A Ag\u00eancia de Prote\u00e7\u00e3o Ambiental (EPA) continua sua revis\u00e3o do dossi\u00ea regulat\u00f3rio do EVOCA nos Estados Unidos. A Biotalys est\u00e1 trabalhando em estreita colabora\u00e7\u00e3o com a EPA para avan\u00e7ar o dossi\u00ea para um resultado bem-sucedido e planeja fornecer uma atualiza\u00e7\u00e3o sobre a revis\u00e3o da EPA em conjunto com o comunicado \u00e0 imprensa sobre os resultados de fim de ano da empresa e o webcast para investidores agendado para 19 de mar\u00e7o de 2025.<\/p>\n<p>Paralelamente \u00e0 EPA, o California Department of Pesticide Regulation (CDPR) tem revisado o dossi\u00ea regulat\u00f3rio para EVOCA submetido pela Biotalys. Conforme anunciado anteriormente, a empresa entende que o CDPR finalizou sua pr\u00f3pria revis\u00e3o aprofundada, abrindo caminho para uma aprova\u00e7\u00e3o r\u00e1pida em n\u00edvel estadual, aguardando a aprova\u00e7\u00e3o do produto pela EPA em n\u00edvel federal.<\/p>","protected":false},"excerpt":{"rendered":"<p>A Biotalys, uma empresa de Tecnologia Agr\u00edcola (AgTech) que desenvolve solu\u00e7\u00f5es de biocontrole baseadas em prote\u00ednas para prote\u00e7\u00e3o sustent\u00e1vel de cultivos, fornece hoje uma atualiza\u00e7\u00e3o sobre\u2026<\/p>","protected":false},"author":1477,"featured_media":41620,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4,1604,22,18,489],"tags":[],"class_list":["post-78411","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-agrochemicals","category-agtech","category-biopesticides","category-fungicides","category-industry-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Biotalys Provides Regulatory Review Update on EVOCA - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"Biotalys, an Agricultural Technology (AgTech) company developing protein-based biocontrol solutions for sustainable crop protection, today provides an\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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