{"id":135722,"date":"2026-11-09T11:32:32","date_gmt":"2026-11-09T16:32:32","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=135722"},"modified":"2026-11-09T11:32:32","modified_gmt":"2026-11-09T16:32:32","slug":"5-factors-affecting-cros-in-asia","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/markets\/asia\/5-factors-affecting-cros-in-asia\/","title":{"rendered":"5 fatores que afetam as CROs na \u00c1sia"},"content":{"rendered":"

Com a evolu\u00e7\u00e3o das regulamenta\u00e7\u00f5es e a acelera\u00e7\u00e3o da inova\u00e7\u00e3o agr\u00edcola, as organiza\u00e7\u00f5es de pesquisa contratada (CROs) est\u00e3o aprimorando suas estrat\u00e9gias para ajudar as empresas a se manterem atualizadas sobre as mudan\u00e7as regulat\u00f3rias, as tecnologias emergentes e as necessidades em constante evolu\u00e7\u00e3o dos produtores. Edward Qin, Gerente de Desenvolvimento de Neg\u00f3cios, China., Estafilo<\/a>, e Arthur Putt, Diretor T\u00e9cnico para a Am\u00e9rica do Norte, Smithers Ci\u00eancias de Risco Ambiental,<\/a> Apresente cinco caracter\u00edsticas principais que definem o trabalho das CROs na regi\u00e3o.<\/p>\n

1. A digitaliza\u00e7\u00e3o moderniza o cen\u00e1rio<\/strong><\/h2>\n

Segundo Putt, os \u00f3rg\u00e3os reguladores em toda a \u00c1sia est\u00e3o acelerando a transi\u00e7\u00e3o para a conformidade digital obrigat\u00f3ria, com as ag\u00eancias exigindo cada vez mais a captura eletr\u00f4nica de dados, trilhas de auditoria digitais e sistemas de Boas Pr\u00e1ticas de Laborat\u00f3rio (BPL) baseados em nuvem para garantir rastreabilidade, transpar\u00eancia e acessibilidade transfronteiri\u00e7a.<\/p>\n

\u201cIsso est\u00e1 alinhado com as tend\u00eancias mais amplas da regi\u00e3o \u00c1sia-Pac\u00edfico (APAC) em dire\u00e7\u00e3o a uma supervis\u00e3o digital prescritiva, o oposto de \u2018escrever um procedimento operacional padr\u00e3o e esperar que seja seguido\u2019, onde os reguladores esperam provas de controles reais\u201d, diz Putt.<\/p>\n

Isso significa que as CROs devem investir fortemente em plataformas e-GLP, ferramentas automatizadas de rastreamento de estudos e solu\u00e7\u00f5es seguras de resid\u00eancia de dados que atendam aos requisitos espec\u00edficos de cada pa\u00eds (por exemplo, as rigorosas regras de dados transfronteiri\u00e7os do Vietn\u00e3).<\/p>\n

\u201cA digitaliza\u00e7\u00e3o deixou de ser opcional\u201d, afirma Putt. \u201cAs CROs que n\u00e3o se modernizarem correm o risco de perder a aprova\u00e7\u00e3o regulat\u00f3ria, a confian\u00e7a dos patrocinadores e a capacidade de conduzir estudos em v\u00e1rios pa\u00edses, em um cen\u00e1rio de conformidade digital cada vez mais fragmentado na \u00c1sia.\u201d<\/p>\n

2. CROS: Construir uma Rede Global<\/strong><\/h2>\n

Uma empresa pode estar sediada na China ou na \u00cdndia, enquanto seus pa\u00edses-alvo para registro s\u00e3o o Brasil, a UE e os EUA. Al\u00e9m disso, os laborat\u00f3rios GLP concorrentes podem estar na Austr\u00e1lia, no Brasil, na China e na \u00cdndia, cada um com compet\u00eancias diferentes, seja em toxicologia, qu\u00edmica ou agroneg\u00f3cio local.<\/p>\n

Qin afirma que essa tend\u00eancia levou as CROs a criarem uma rede global ou, pelo menos, a serem a fonte local de informa\u00e7\u00f5es regulat\u00f3rias.<\/p>\n

\u201cSomente com uma rede global e conhecimento do mercado, a CRO (Organiza\u00e7\u00e3o de Receitas Civis) consegue ser competitiva no suporte aos clientes\u201d, afirma Qin.<\/p>\n

3. A consolida\u00e7\u00e3o transfronteiri\u00e7a gera plataformas de CRO multinacionais<\/strong><\/h2>\n

Segundo Putt, as CROs de m\u00e9dio porte na \u00cdndia, China, Jap\u00e3o e Sudeste Asi\u00e1tico est\u00e3o acelerando fus\u00f5es, aquisi\u00e7\u00f5es e parcerias estrat\u00e9gicas para criar plataformas regionais unificadas capazes de executar estudos harmonizados em m\u00faltiplas jurisdi\u00e7\u00f5es regulat\u00f3rias.<\/p>\n

Na \u00c1sia, o aumento dos custos da transforma\u00e7\u00e3o digital e a demanda por uma execu\u00e7\u00e3o transfronteiri\u00e7a perfeita, protocolos de teste consistentes e pacotes de dados que atendam \u00e0s diversas autoridades nacionais sem testes duplicados tamb\u00e9m contribuem para essa tend\u00eancia, afirma Putt.<\/p>\n

\u201cAs CROs est\u00e3o cada vez mais formando alian\u00e7as que lhes permitem coordenar ensaios de campo na \u00cdndia, estudos de res\u00edduos no Jap\u00e3o e avalia\u00e7\u00f5es baseadas em risco na China sob uma \u00fanica estrutura operacional\u201d, afirma Putt. \u201cO resultado \u00e9 uma nova gera\u00e7\u00e3o de redes regionais de CROs projetadas para reduzir a fragmenta\u00e7\u00e3o, simplificar os processos regulat\u00f3rios e oferecer aos patrocinadores uma solu\u00e7\u00e3o completa para a regi\u00e3o da \u00c1sia-Pac\u00edfico.\u201d<\/p>\n

4. Mudan\u00e7as regulat\u00f3rias significativas remodelam a demanda<\/strong><\/h2>\n

Segundo Putt, os marcos regulat\u00f3rios em toda a \u00c1sia est\u00e3o passando por atualiza\u00e7\u00f5es r\u00e1pidas e de alto impacto que afetam diretamente a opera\u00e7\u00e3o das CROs (Organiza\u00e7\u00f5es de Pesquisa Cl\u00ednica).<\/p>\n

Por exemplo, o Minist\u00e9rio da Agricultura e Assuntos Rurais da China prop\u00f4s uma grande revis\u00e3o dos requisitos de dados sobre pesticidas, passando para um modelo de avalia\u00e7\u00e3o mais simplificado e baseado no risco, que poderia reduzir os testes gen\u00e9ricos de rotina, mas aumentar a demanda por estudos ambientais e toxicol\u00f3gicos complexos.<\/p>\n

A \u00cdndia est\u00e1 modernizando sua legisla\u00e7\u00e3o sobre pesticidas, com forte \u00eanfase na conformidade digital, aprova\u00e7\u00f5es de produtos mais r\u00e1pidas e uma proposta de reformula\u00e7\u00e3o das principais estruturas regulat\u00f3rias \u2014 mudan\u00e7as que exigir\u00e3o que as CROs (Organiza\u00e7\u00f5es de Pesquisa Cl\u00ednica) digitalizem seus fluxos de trabalho e gerenciem um aumento nos ensaios de campo em m\u00faltiplos locais.<\/p>\n

A Ag\u00eancia de Assuntos do Consumidor do Jap\u00e3o continua a apertar os limites m\u00e1ximos de res\u00edduos, atualizando os limites para v\u00e1rios produtos qu\u00edmicos agr\u00edcolas em meados de 2026, refor\u00e7ando seu sistema de lista positiva e impulsionando a demanda por verifica\u00e7\u00e3o anal\u00edtica ultraprecisa.<\/p>\n

\u201cEssas mudan\u00e7as refletem um aperto regulat\u00f3rio mais amplo na regi\u00e3o da \u00c1sia-Pac\u00edfico, onde os \u00f3rg\u00e3os reguladores est\u00e3o se tornando mais prescritivos e focados na aplica\u00e7\u00e3o da lei\u201d, diz Putt. \u201cPara as CROs, o efeito combinado \u00e9 uma mudan\u00e7a de foco, deixando de lado os estudos de gen\u00e9ricos em grande volume e se voltando para a ci\u00eancia regulat\u00f3ria especializada e de alta margem de lucro \u2014 com uma press\u00e3o crescente para fornecer pacotes de dados digitais, defens\u00e1veis e espec\u00edficos para cada pa\u00eds.\u201d<\/p>\n

5. A CROS estabelece um sistema de apoio abrangente.<\/strong><\/h2>\n

\u00c0 medida que as CROs se concentram nas tend\u00eancias regulat\u00f3rias e fornecem solu\u00e7\u00f5es de licenciamento local, elas tamb\u00e9m devem permanecer pr\u00f3ximas do mercado e ajudar os clientes a vincular as licen\u00e7as \u00e0s vendas locais, afirma Qin.<\/p>\n

\u201cAs CROs devem fornecer suporte de \u2018gest\u00e3o\u2019 juntamente com as licen\u00e7as de registro\u201d, diz Qin. \u201cA CRO tamb\u00e9m deve fornecer suporte para gera\u00e7\u00e3o de dados GLP, avalia\u00e7\u00e3o quantitativa da rela\u00e7\u00e3o estrutura-atividade, efic\u00e1cia em campo local e ensaios de res\u00edduos, al\u00e9m do suporte para submiss\u00e3o regulat\u00f3ria. As CROs devem participar dos projetos desde o in\u00edcio, nos estudos de viabilidade e na fase de gera\u00e7\u00e3o de dados.\u201d<\/p>\n

CROs na China<\/h2>\n

Especificamente na China, Qin observa diversos outros fatores emergentes no setor que determinar\u00e3o o funcionamento das CROs.<\/p>\n

1. Inscri\u00e7\u00f5es globais.<\/strong> Com o surgimento de mol\u00e9culas mais inovadoras, as empresas preferem lan\u00e7ar estudos de viabilidade de registro global e realizar esse tipo de pr\u00e1tica.<\/p>\n

\u201cAs grandes empresas focam-se em \u2018grandes mol\u00e9culas\u2019 e gostariam de discutir os registos globais, tanto de terapia g\u00eanica como de formula\u00e7\u00f5es relevantes\u201d, afirma Qin.<\/p>\n

2. Contatos locais.<\/strong> O registro local passa a ser associado \u00e0 entrada no mercado.<\/p>\n

\u201cMais empresas chinesas tentaram estabelecer entidades locais e contratar pessoas locais para as opera\u00e7\u00f5es comerciais\u201d, diz Qin. \u201cO trabalho dos CROs n\u00e3o \u00e9 apenas o registro, mas tamb\u00e9m o suporte na conformidade local das pr\u00e1ticas comerciais.\u201d<\/p>","protected":false},"excerpt":{"rendered":"

Regulatory experts in Asia delve into developments influencing how contract research organizations (CROs) operate in the region.<\/p>","protected":false},"author":2163,"featured_media":135740,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[1917,28,5],"tags":[2027,54],"class_list":["post-135722","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-abg-update-feature","category-asia","category-markets","tag-abg-november-2026","tag-featured-home"],"yoast_head":"\n5 Factors Affecting CROs in Asia - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"Regulatory experts in Asia delve into developments influencing how contract research organizations (CROs) operate in the region. 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