New Regulations Implemented, Drug Safety Secured | ASY Anti-Counterfeiting Helps Pharmaceutical Industry Compliance Traceability Upgrade
On May 15, 2026, the revised Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China(hereinafter referred to as the “New Regulations”) officially took effect, setting rigid standards and clarifying responsibility boundaries for anti-counterfeiting traceability in the pharmaceutical industry. Article 64 of the New Regulations explicitly requires that drug marketing authorization holders and manufacturers must affix unique traceability identifiers on packaging, and provide traceability information across the entire chain of production, distribution, and medical institutions, achieving “traceable sources, trackable destinations, and accountable responsibilities.”
Under policy pressure, pain points such as the failure of traditional anti-counterfeiting methods, fragmented traceability data, difficulty in controlling cross-regional sales, and rising compliance costs have erupted intensively for pharmaceutical companies. ASY Anti-Counterfeiting, with years of deep expertise in the field of anti-counterfeiting traceability, precisely aligns with the core requirements of the New Regulations. Centered on drug label anti-counterfeiting plus a full-chain traceability system, ASY provides an integrated solution tailored for the pharmaceutical industry, helping enterprises achieve rapid compliance and strengthen drug safety defenses.
ASY Anti-Counterfeiting closely follows the New Regulations’ requirements, integrating physical anti-counterfeiting technology, digital traceability systems, and intelligent verification terminals. Targeting four core needs of the pharmaceutical industry — drug label management, anti-counterfeiting verification, full-chain traceability, and cross-regional sales control — ASY builds a closed-loop system featuring “one product, one code; one drug, one label; full-process traceability; authenticity verifiable.” This system covers all scenarios from drug production, circulation, and terminal use to patient consumption.
Drug labels serve as the “first line of defense” for drug identity and the core carrier of traceability identifiers under the New Regulations. ASY offers customized high-security drug label solutions adapted to various packaging types, including medicine boxes, bottles, blister packs, and traditional Chinese medicine packaging bags, balancing anti-counterfeiting performance, aesthetics, and compliance.
Beyond physical barriers to prevent counterfeiting, ASY’s pharmaceutical anti-counterfeiting traceability system is built around “one product, one code,” breaking down data silos across production, circulation, terminal, and regulatory stages. It constructs a full-process traceability loop of “production coding, circulation scanning, terminal code verification, and regulatory code checking,” fully meeting the New Regulations’ requirements for full-chain traceability.
Production End: Coding and Association, Source Controllable
When drugs are produced offline, smart coding equipment assigns a unique traceability code linked in real time to batch numbers, inspection reports, raw material sources, and operator data. This data is uploaded to an encrypted cloud database and cannot be tampered with.
Distribution End: Scan Tracking, Clear Flow
During outbound delivery, inbound receipt, and logistics transport, distributors and logistics companies scan drug label traceability codes via mobile apps or dedicated scanning devices, automatically recording node information, time, location, and handler. Data is uploaded to the system in real time. Companies can view drug flow in real time, accurately locate cross-regional sales violations, and lock down the source with one click, solving channel management challenges.
Terminal End: Verification and Settlement, Compliance Achieved
When hospitals and pharmacies receive drugs, they scan codes to verify authenticity and traceability information, ensuring legal compliance. When patients purchase drugs, they can scan the code via WeChat to check drug authenticity, circulation records, instructions, adverse reactions, and other information, ensuring medication safety.
Regulatory End: Data Integration, Efficient Oversight
The system reserves data interfaces with the national drug traceability platform and local drug regulatory authorities, enabling real-time synchronization of traceability data. It supports regulatory agencies in penetrating inquiries and dynamic supervision, helping companies easily pass compliance inspections and avoid policy risks.
The implementation of the New Regulations presents both challenges and opportunities. For pharmaceutical companies, upgrading anti-counterfeiting traceability systems as early as possible is not only a necessary requirement for policy compliance but also a key measure to ensure drug safety, protect brand reputation, and improve management efficiency.
With years of experience serving the pharmaceutical industry, mature technical systems, and comprehensive implementation capabilities, ASY Anti-Counterfeiting has already helped numerous pharmaceutical companies complete their anti-counterfeiting traceability upgrades, building a strong safety line for drug security and safeguarding public medication safety, thereby contributing to the high-quality development of the pharmaceutical industry.
Be free to consult us on custom anti-counterfeiting solutions to protect your product and brand, help you increase revenue, and build customer loyalty.
