亚太地区的可追溯性

驾驭监管格局:亚太地区监管中心及相关链接

Navigating the Regulatory Landscape

This page offers a centralized view of pharmaceutical compliance across the Asia-Pacific region. Each country entry includes a short regulatory overview and a link to further information. With varying levels of maturity and scope, APAC regulatory landscapes are captured here to support awareness and navigation of evolving pharmaceutical compliance initiatives across the region.

All Regulations

Sri Lanka

The National Medicines Regulatory Authority (NMRA) of Sri Lanka stands as the cornerstone of pharmaceutical safety and quality assurance in the island nation. Established in 2015 through an Act of Parliament, NMRA serves as an independent authority under the Ministry of Health, dedicated to protecting public health by ensuring that all medicinal products, medical devices, and borderline products meet stringent standards of safety, efficacy, and quality throughout the pharmaceutical supply chain.

Taiwan

Taiwan has established one of Asia's most robust pharmaceutical traceability systems, anchored by the Pharmaceutical Affairs Act and comprehensive regulatory oversight. The Taiwan Food and Drug Administration (TFDA) enforces a "full track and trace" system that monitors pharmaceutical products through every stage of the supply chain, from manufacturing to patient delivery. This systematic approach demonstrates Taiwan's unwavering commitment to pharmaceutical safety, supply chain transparency, and public health protection.

Uzbekistan

In Uzbekistan, the government has established one of Central Asia's most comprehensive pharmaceutical traceability frameworks through the ASL BELGISI digital system. Managed by the national operator CRPT Turon and modeled after Russia's proven Chestny ZNAK platform, this robust regulatory structure demonstrates Uzbekistan's commitment to safeguarding public health and ensuring the authenticity of pharmaceutical products throughout the entire supply chain.

中国

在充满活力的中国制药行业中,遵守可追溯性要求不仅仅是监管要求;这是对最高安全性和真实性标准的承诺。受中国食品药品监督管理局(CFDA)管辖,《中国药品电子监控工作计划》和《2019年药品管理法》药品追溯要求经过精心设计,以确保药品在整个供应链中的完整性。

印度中央药品标准控制组织

印度的制药业由各种监管机构管理,遵守可追溯性标准对于确保药品的安全性和完整性至关重要。

澳大利亚 TGA

澳大利亚治疗用品管理局(TGA)是澳大利亚药品监管的基石,隶属于卫生和老年护理部。通过严格执行1989年《治疗用品法》及相关法规,TGA确保澳大利亚市场上的所有治疗产品均符合严格的安全、质量和疗效标准,从而保护公共健康并增强消费者的信心。

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