{"editorial":{"content_id":"7be819a5-f9e7-44d4-8cd9-7623f7118da6","slug":"anvisa-rdc-siptox-20261106-780fad","content_type":"news","title":"巴西Anvisa发布RDC 1.047/2026，废止农药毒理简化程序并迁移SIPTOX流程","summary":"巴西国家卫生监督局发布RDC 1.047/2026，废止RDC 184/2017，将SIPTOX系统分析的农药登记毒理流程迁入常规监管程序。","body":"巴西国家卫生监督局（Anvisa）于周五（11月6日）发布董事会决议RDC 1.047/2026，废止RDC 184/2017，并规定将经毒理学申报系统（SIPTOX）分析的程序迁移至该局常规监管程序。\n\n被废止的RDC 184/2017曾规定农药登记毒理学分析的简化程序，当时旨在提高分析效率、减少积压。Anvisa表示，随着农药登记毒理评估新规实施、监管框架变化以及登记信息系统更新，维持该简化程序已无必要，且与现行监管现实不符。\n\n原文列举的变化包括：2023年第14.785号法律设立统一信息、申报和电子评估系统（Sispa），实施全球化学品统一分类和标签制度（GHS），以及2024年第950号决议等处理农药登记申请排队的规范。\n\n新决议规定，基于RDC 184/2017注册的产品不再适用简化程序，须遵循现行监管程序；等待简化程序分析的过程将按各类产品适用的标准和要件分析，企业须按产品归类提交现行法规要求的研究和技术文件。已完成程序的企业须提供数据转让函，在迁移至Sispa或提交产品首个上市后申报时出示。\n\nAnvisa称，过渡机制旨在保障已完成的分析，确保待审程序和已获毒理评估通过的程序均能继续推进，并使这些产品全面纳入现行系统和流程，与其他须经毒理评估的产品获得统一对待。Anvisa建议登记负责人开始规划新规要求的行动，以确保产品合规和监管流程延续。","why_it_matters":null,"cbi_observation":null,"direction_tag":"巴西","primary_category":"科技平台","secondary_topics":["政策","合规","行业趋势","br-health"],"content_level":"编辑整理","event_type":"政策法规","audience_tags":["在巴西从事农药登记的企业"],"event_location":null,"verification_status":"source_verified","published_at":"2026-11-06T23:01:07.043Z","display_date":"2026-11-06","source_published_at":null,"source_url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-publica-norma-de-migracao-do-siptox-e-encerra-o-uso-do-sistema","source_name":"Anvisa","source_language":"pt","author_name":"编辑部","risk_level":"low","risk_flags":[],"opportunity_flags":[],"trend_signals":[]},"intelligence":null,"meta":{"canonical_url":"https://chinabrazilinsight.com/news/anvisa-rdc-siptox-20261106-780fad","api_url":"https://chinabrazilinsight.com/api/public/content/anvisa-rdc-siptox-20261106-780fad","markdown_url":"https://chinabrazilinsight.com/api/public/content/anvisa-rdc-siptox-20261106-780fad?view=markdown","json_url":"https://chinabrazilinsight.com/api/public/content/anvisa-rdc-siptox-20261106-780fad?view=json","last_updated":"2026-11-06T23:01:32.394Z","platform":"China Brazil Insight","platform_url":"https://chinabrazilinsight.com"}}