The Drug Electronic Supervision Code, abbreviated as “Drug Supervision Code,” is a system facilitated by the CSJ-UV512 Drug Supervision Code UV Marking System. This system enables the printing of drug boxes with unique identification codes to manage and oversee the status of drugs throughout their production and distribution processes. It aims to provide real-time supervision by regulatory authorities and manufacturing companies, enabling product traceability and management to protect the legal rights of drug manufacturers and consumers.
English Name: Drug Electronic Supervision Code
Function: To safeguard the interests of drug manufacturers and consumers
Regulatory Authority: National Medical Products Administration
Definition:
The Drug Electronic Supervision Code management system specifically targets the supervision of drug status throughout its production and distribution, facilitating traceability and management by regulatory bodies and production companies to protect the legal rights of drug manufacturers and consumers.
Equipment Used: The Drug Supervision Code UV Marking System, which implements a unique code for each item.
Purpose: Utilizes the nationwide National Drug Supervision Network platform for product status inquiries, traceability, and management.
Functions:
- Monitoring the entire process from production, distribution, transportation, storage, to delivery to medical institutions by the drug regulatory authorities.
- Enabling real-time inquiries into the production, business operations, stock levels, and distribution of each box, case, or batch of key drugs for swift traceability and recall if issues arise.
- Information early warning systems for:
- Over-qualification production and business operation warnings for companies.
- Drug sales quantity anomaly warnings, indicating possible drug misuse or potential disease outbreak alerts if a drug is sold in large quantities in a short period.
- Drug shipment and receipt quantity and variety verification warnings to detect potential drug loss promptly.
- Mobile enforcement for drug regulation and inspection personnel through the internet or mobile devices for timely on-site inspections.
Query Method:
Consumers can enter the Drug Electronic Supervision Code, area code, and telephone number on the China Drug Electronic Supervision website to directly access information about the drug, including its common name, dosage form, formulation, packaging specifications, manufacturer, production date, batch number, expiration date, approval number, and drug distribution. If it’s not the first inquiry, previous query records will be displayed.
Overview:
On June 17, 2010, the State Food and Drug Administration (SFDA) issued a notice requiring companies producing essential drug varieties to join the Drug Electronic Supervision Network by March 31, 2011. This initiative encompasses encoding, verification, and self-warning systems for these companies. Following anesthetics, psychotropic drugs, blood products, vaccines, and Chinese herbal injections, 307 essential drug varieties are also included in the electronic supervision scope. The Drug Electronic Supervision Code uniquely identifies each product, acting like an identity card for the product, also known as the supervision code. The code has been upgraded from 16 to 20 digits, allowing for a direct correlation with product barcodes for retail pricing and settlement functions. Manufacturers transmit production and quality information to the regulatory database via the electronic supervision code, while distribution companies use it for receiving goods and transmitting sales information, enabling consumers, government agencies, and companies to access data for authenticity checks, enforcement, quality traceability, product recalls, and market analysis.
Features:
- One code per item: Each product is uniquely identified and tracked throughout its lifecycle, unifying government regulation, logistics, merchant settlement, and consumer inquiries.
- Centralized database storage for dynamic information: Overcoming limitations of pre-printed quality and distribution information by storing real-time product data in a large-scale regulatory database.
- Nationwide coverage: A unified, seamless system network platform is essential for comprehensive supervision due to the nationwide distribution of locally produced products.
- Full-cycle regulatory network: Capturing closed-loop information from production to consumption, including quality inspection, industrial and commercial administration, commerce, and drug regulation, facilitating information sharing and process linkage among relevant departments.
- Consumer inquiries: Enabling convenient access to real drug authenticity and quality information via SMS, phone, the internet, and terminal actions. If issues are detected, consumers can contact local food and drug regulatory departments.
Impact Analysis:
The regulatory network allows production and distribution companies to quickly understand market conditions, protect intellectual property rights, and manage logistics. Consumers can verify product authenticity and quality, while regulatory enforcement departments can promptly address counterfeit and illegal product information, trace quality issues, and manage recalls efficiently, combining government oversight, corporate self-regulation, and social supervision to promote a harmonious society. This system ensures close monitoring of drugs from production to consumption, facilitating rapid traceability and minimizing recall costs in case of issues.
Implementation Process:
The realization of the Drug Electronic Supervision Code relies on the Drug Supervision Code encoding system, including code acquisition, allocation, printing or marking, scanning, and uploading and querying drug codes and information.
