确保药品安全:加拿大的卫生监管框架

加拿大的健康监管框架

在加拿大,加拿大卫生部是中央监管机构,负责通过对药品的全面监督来保障公共健康。加拿大的监管框架以药品识别码(DIN)系统为基础,该系统构成了该国对整个供应链中药品可追溯性、安全和质量保证的承诺的支柱。

药物识别码 (DIN) 系统

加拿大卫生部为获准在加拿大销售的每种药品分配一个唯一的药物识别号。此标识符是处方药和非处方药的必备标识符,可以精确跟踪整个分销网络并确保供应链的完整性。DIN 是产品识别、上市后监测、召回和质量监控的关键工具。

全面的通知要求

在加拿大经营的制药实体必须遵守严格的通知协议。制造商必须向加拿大卫生部报告产品何时首次发售、产品在12个月内未售出或何时停止销售。年度通知要求进一步要求制造商在每年10月1日之前向加拿大卫生部通报每种DIN产品的状态。

批次级可追溯性

加拿大的监管框架强调整个药品供应链的批次级可追溯性。最近的更新要求制造商在通知停止销售时提交具体的批号,从而增强了精确跟踪产品的能力。该系统支持药品的高效召回管理和强大的上市后监控。

数据库集成和透明度

所有带有指定DIN的授权药品均记录在加拿大卫生部的药品数据库中,从而创建了一个可供医疗保健专业人员和监管机构访问的集中信息存储库。这种集成支持全面的可追溯性,同时提高整个制药生态系统的透明度。该数据库是核查和合规监测的关键资源。

Why Choose Our iTS Compliance Solution

Expert Guidance

Our team of compliance experts possesses in-depth knowledge of iTS and Turkish pharmaceutical regulations. From serialization strategies to data reporting, we guide your organization through the intricacies of compliance, ensuring a smooth and informed journey.

Cutting-Edge Technology

Leverage our state-of-the-art compliance solution, designed to integrate seamlessly with iTS requirements. Our technology ensures accuracy, efficiency, and real-time visibility, empowering your organization to meet and exceed compliance expectations.

Future-Ready Operations

Compliance is not just about meeting today's standards; it's about preparing for the future. Our solution is designed to evolve with regulatory changes, ensuring that your organization remains at the forefront of compliance in the dynamic Turkish pharmaceutical landscape.

Transparent Collaboration

We believe in transparent collaboration. Partner with us, and we'll work closely with your team to implement and maintain compliance measures. Our goal is to build a resilient, compliant, and future-ready pharmaceutical supply chain together.

Speak With a Compliance Expert

我们在加拿大卫生部合规方面的专业知识

满足加拿大的药品监管要求需要专业的知识和技术解决方案。我们的团队提供专为加拿大市场设计的量身定制的合规系统。从DIN注册支持到实施通知协议和批次级跟踪功能,我们提供符合加拿大卫生部要求的全面解决方案。我们的专业知识可帮助制药组织建立强大的可追溯系统,确保合规性,同时支持安全和透明的供应链。retryClaude 可能会犯错误。请仔细检查回复。

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