Pharma traceability code rules countdown — Code-based drug supervision new era
Release time:2025-06-13
On March 19, 2025, the National Healthcare Security Administration, jointly with the Ministry of Human Resources and Social Security, the National Health Commission, and the National Medical Products Administration, issued the "Notice on Strengthening the Collection and Application of Drug Traceability Codes in the Fields of Medical Security and Work Injury Insurance," clearly stipulating that, starting July 1, 2025, medical institutions designated for medical insurance must scan the traceability code before processing medical insurance fund settlements when selling drugs.
The new regulations require marketing authorization holders and manufacturers to assign unique codes to all levels of sales packaging units, ensuring the accuracy and uniqueness of drug traceability codes. By January 1, 2026, all pharmaceutical institutions must achieve full-scale collection and upload of drug traceability codes.
The new regulations require that stable and accurate “one product, one code” labeling be implemented at the smallest sales packaging unit (such as a single box or bottle), and ensure that the traceability codes at all levels of packaging (boxes, cartons, bottles) are correctly linked in a cascading manner.
How can we ensure clear, scratch-resistant, and corrosion-resistant traceability codes are accurately printed on pharmaceutical packages of various materials and specifications along a high-speed production line? How can we guarantee the precise and error-free cascading mapping relationship among large, medium, and small packaging units, thereby preventing data discontinuities?
According to Guangzhou Huiyi, this calls for a highly reliable and easily integrable automated coding solution:
Step 1: Packaging triggers coding.
When pharmaceutical packaging (bottles, boxes, or cartons) enters the production line, sensors (photoelectric switches or encoders) trigger the coding equipment (inkjet printers, laser markers, or TTO thermal transfer printers). The equipment prints a unique traceability code onto the moving packaging surface at speeds typically ranging from 100 to 600 units per minute.
Step 2: Multi-level packaging association (three-level association)
Data collection:
After the smallest unit (bottle/plate) is coded, the scanner immediately collects its code data.
When the secondary packaging (box) is loaded into the smallest unit, the system automatically generates a box code and establishes a “box-to-bottle” association (e.g., 1 box is associated with 10 bottles).
When large packages (boxes) are placed into medium-sized boxes, a box code is generated and a “box-to-box” association is established (e.g., 1 box is associated with 20 boxes).
Step 3: Quality Verification and Removal
Real-time detection: The vision system (CCD camera) performs a 5-fold verification on each code:
✅ Readability (whether it can be scanned)
✅ Contrast (Clarity)
✅ Position offset (within ±0.5mm)
✅ Content accuracy (consistent with the system-generated code)
✅ Correctness of cascading association (parent-child code matching)
Automatic rejection: Non-conforming packaging is ejected from the production line by a pneumatic device, preventing incorrect data from flowing downstream.
Step 4: Data Upload and Integration
Local storage: Associated data is written to a local database (SQL/NoSQL) in real time.
Platform Integration: Automatically synchronized to via API/EDI:
Enterprise ERP/WMS System
National Pharmaceutical Traceability Platform (such as the China National Medical Products Administration’s NMPA Traceability System)
Third-party regulatory platforms (such as the Medical Insurance Bureau)
The implementation timetable for the new regulations has been finalized, and the pharmaceutical industry’s demand for compliant, efficient coding and scanning equipment is rapidly increasing. Choosing an equipment partner with deep industry experience and strong technical capabilities is a crucial step in ensuring a smooth transition and seizing market opportunities.
Guangzhou Huiyi specializes in the pharmaceutical traceability field and boasts mature technological solutions as well as extensive implementation experience. If you’re looking for a reliable coding or scanning solution to meet upcoming new regulations, we’d love to hear from you and discuss how we can provide robust technical support for your production or distribution processes.
Relevant information
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