China Work Plan for Pharmaceutical Electronic Monitoring

Ministry of Food and Drug Safety Pharmaceutical Traceability Requirements

DSCSA Track and Trace Compliance Solutions

Navigating Pharmaceutical Traceability in China's Regulatory Landscape

In the vibrant landscape of China's pharmaceutical industry, adherence to traceability requirements is not just a regulatory mandate; it's a commitment to the highest standards of safety and authenticity. Governed by China's Food and Drug Administration (CFDA), the China Work Plan for Pharmaceutical Electronic Monitioring and 2019 Drug Administration Law pharmaceutical traceability requirements have been meticulously designed to ensure the integrity of medicinal products across the supply chain.

China Work Plan for Pharmaceutical Electronic Monitoring

Key Elements of China's Pharmaceutical Traceability Requirements

Unique Identification and Serialization

Each pharmaceutical product is mandated to bear a unique identifier and serialization, facilitating precise tracking and tracing. This digital footprint ensures the authenticity and origin of pharmaceuticals throughout their lifecycle.

Comprehensive Data Reporting

Companies are obligated to submit detailed data at various stages of the supply chain, encompassing production, distribution, and sales. This data-centric approach empowers regulatory authorities to monitor pharmaceutical movement effectively and respond promptly to any irregularities.

Strategic Compliance Measures

Stringent compliance oversight, including regular inspections and audits, is enforced to assess and ensure adherence to traceability regulations. Non-compliance may lead to severe consequences, emphasizing the importance of proactive compliance measures.

Global Integration

Aligning with international standards, China's traceability requirements promote interoperability, facilitating seamless global trade in pharmaceuticals.


For pharmaceutical entities navigating the Chinese market, embracing these traceability requirements is not just a regulatory necessity but a strategic imperative. Our cutting-edge solutions empower your organization to navigate these requirements seamlessly, ensuring compliance, transparency, and the highest standards of pharmaceutical safety in China. Elevate your operations – choose compliance, choose excellence.

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