{"id":133838,"date":"2025-02-01T13:57:41","date_gmt":"2025-02-01T18:57:41","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=133838"},"modified":"2026-01-29T13:58:50","modified_gmt":"2026-01-29T18:58:50","slug":"experts-give-top-three-developments-for-chinas-cros-in-2025","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/markets\/asia\/experts-give-top-three-developments-for-chinas-cros-in-2025\/","title":{"rendered":"Especialistas d\u00e3o os tr\u00eas principais desenvolvimentos para as CROs da China em 2025"},"content":{"rendered":"<p>As Contract Research Organizations (CROs) est\u00e3o prontas para desempenhar um papel cada vez mais fundamental na ind\u00fastria agroqu\u00edmica da China, \u00e0 medida que ela se concentra em tecnologias mais verdes e sustent\u00e1veis. Tr\u00eas l\u00edderes da ind\u00fastria d\u00e3o seus tr\u00eas principais desenvolvimentos que moldam o din\u00e2mico setor de CROs em 2025 e uma lista de verifica\u00e7\u00e3o de 7 perguntas.<\/p>\n<p><strong>Eduardo Qin<\/strong><br \/>\n<strong>Gerente de Desenvolvimento de Neg\u00f3cios<\/strong><br \/>\n<strong>Estafilo<\/strong><\/p>\n<p><strong>1. Apoio aos pr\u00e9-estudos<\/strong><br \/>\nAs CROs chinesas precisam facilitar pr\u00e9-estudos para ajudar patrocinadores locais a entender projetos regulat\u00f3rios. Os servi\u00e7os devem incluir triagem de amostras, confirma\u00e7\u00e3o de impurezas, desenvolvimento de m\u00e9todos anal\u00edticos e s\u00edntese de amostras de impurezas.<\/p>\n<p><strong>2. Sinergia em registros somente para exporta\u00e7\u00e3o<\/strong><br \/>\nDesde 2019, a categoria de registro somente para exporta\u00e7\u00e3o do China ICAMA permite que os patrocinadores usem um \u00fanico projeto para dar suporte a registros nacionais e internacionais, minimizando estudos duplicados e garantindo a consist\u00eancia dos dados.<\/p>\n<p><strong>3. Colabora\u00e7\u00e3o com laborat\u00f3rios GLP no exterior<\/strong><br \/>\nAs CROs chinesas se destacam em estudos relacionados \u00e0 qu\u00edmica e frequentemente terceirizam estudos biol\u00f3gicos para laborat\u00f3rios nos pa\u00edses de destino, garantindo a conformidade com as pr\u00e1ticas regulat\u00f3rias locais.<\/p>\n<p><strong>Eduardo Qin<\/strong><br \/>\n<strong>Gerente de Desenvolvimento de Neg\u00f3cios<\/strong><br \/>\n<strong>Estafilo<\/strong><\/p>\n<p><strong>1. Apoio aos pr\u00e9-estudos<\/strong><br \/>\nAs CROs chinesas precisam facilitar pr\u00e9-estudos para ajudar patrocinadores locais a entender projetos regulat\u00f3rios. Os servi\u00e7os devem incluir triagem de amostras, confirma\u00e7\u00e3o de impurezas, desenvolvimento de m\u00e9todos anal\u00edticos e s\u00edntese de amostras de impurezas.<\/p>\n<p><strong>2. Sinergia em registros somente para exporta\u00e7\u00e3o<\/strong><br \/>\nDesde 2019, a categoria de registro somente para exporta\u00e7\u00e3o do China ICAMA permite que os patrocinadores usem um \u00fanico projeto para dar suporte a registros nacionais e internacionais, minimizando estudos duplicados e garantindo a consist\u00eancia dos dados.<\/p>\n<p><strong>3. Colabora\u00e7\u00e3o com laborat\u00f3rios GLP no exterior<\/strong><br \/>\nAs CROs chinesas se destacam em estudos relacionados \u00e0 qu\u00edmica e frequentemente terceirizam estudos biol\u00f3gicos para laborat\u00f3rios nos pa\u00edses de destino, garantindo a conformidade com as pr\u00e1ticas regulat\u00f3rias locais.<\/p>\n<p><strong>Margarida Hu<\/strong><br \/>\n<strong>Consultor Principal em Assuntos Regulat\u00f3rios<\/strong><br \/>\n<strong>Alcance24H<\/strong><\/p>\n<p><strong>1. Pesticidas verdes e biol\u00f3gicos<\/strong><br \/>\nA crescente demanda por solu\u00e7\u00f5es ecol\u00f3gicas e sustent\u00e1veis, incluindo suspens\u00f5es de microc\u00e1psulas e pesticidas biol\u00f3gicos, significa que as CROs (Organiza\u00e7\u00f5es de Pesquisa Cl\u00ednica) devem responder \u00e0s metas de agricultura verde do pa\u00eds. &quot;O compromisso da China com a agricultura verde e o desenvolvimento sustent\u00e1vel est\u00e1 impulsionando as CROs a inovar, desde formula\u00e7\u00f5es de baixa toxicidade at\u00e9 tecnologias de libera\u00e7\u00e3o precisa, sempre garantindo a conformidade com os padr\u00f5es locais e internacionais&quot;, afirma Hu.<\/p>\n<p><strong>2. Capacidades de servi\u00e7o aprimoradas<\/strong><br \/>\nAs CROs devem ter alinhamento expandido com padr\u00f5es internacionais, dando suporte a registros multinacionais para conformidade eficiente de mercado duplo.<\/p>\n<p><strong>3. Inova\u00e7\u00f5es digitais<\/strong><br \/>\nA integra\u00e7\u00e3o de intelig\u00eancia artificial e ferramentas digitais para gerenciamento simplificado de projetos e maior precis\u00e3o de dados \u00e9 essencial ao trabalhar com um CRO em 2025.<\/p>\n<h2>Lista de verifica\u00e7\u00e3o de 7 perguntas do CRO da China<\/h2>\n<p>\u00c0 medida que o ambiente regulat\u00f3rio da China evolui, as CROs continuam sendo parceiras essenciais para empresas que buscam navegar por requisitos complexos e obter registros de produtos bem-sucedidos. Ao selecionar uma CRO, considere as perguntas sugeridas por nossos tr\u00eas especialistas.<\/p>\n<ol>\n<li>O CRO tem familiaridade com as diretrizes MARA e os padr\u00f5es internacionais?<\/li>\n<li>Voc\u00ea verificou a experi\u00eancia do CRO em categorias de produtos relevantes e projetos complexos?<\/li>\n<li>O CRO tem estruturas de comunica\u00e7\u00e3o e mecanismos de resolu\u00e7\u00e3o de problemas robustos?<\/li>\n<li>O CRO entende os crit\u00e9rios de equival\u00eancia e os requisitos regulat\u00f3rios para este projeto?<\/li>\n<li>O dossi\u00ea pode ser usado para submiss\u00f5es globais em mercados importantes como UE, EUA, Brasil e Austr\u00e1lia?<\/li>\n<li>O CRO pode auxiliar com avalia\u00e7\u00e3o de amostra, aquisi\u00e7\u00e3o de padr\u00e3o de impureza e desenvolvimento de m\u00e9todo? Eles t\u00eam experi\u00eancia adequada para lidar com inqu\u00e9ritos governamentais?<\/li>\n<li>O CRO tem fortes habilidades de coordena\u00e7\u00e3o para atender \u00e0s diferentes demandas de diferentes prov\u00edncias?<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>As Organiza\u00e7\u00f5es de Pesquisa Contratada (CROs, na sigla em ingl\u00eas) est\u00e3o prestes a desempenhar um papel cada vez mais crucial na ind\u00fastria agroqu\u00edmica da China, \u00e0 medida que esta se concentra em\u2026<\/p>","protected":false},"author":110,"featured_media":78401,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[28],"tags":[1985],"class_list":["post-133838","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-asia","tag-abg-direct-february-2025"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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