China
As to the pharmaceutical product traceability system in China, we should first talk about the pharmaceutical product electronic supervision code (ESC). China’s pharmaceutical product ESC management system is to supervise status of pharmaceutical products during production and circulation, achieve product tracing and management by regulators and manufacturers, and protect legitimate rights and interests of pharmaceutical product manufacturers and consumers.
Sudden stop of the 10-year process of the ESC
The former China Food and Drug Administration (CFDA) began to implement the pharmaceutical product electronic supervision work early in 2006, in order to strengthen the pharmaceutical product electronic supervision, improve the public’s medication safety, and achieve all-variety and whole-process supervision of pharmaceutical products.
Like the ID card of pharmaceutical product, the pharmaceutical product supervision code is the unique bar code of every pharmaceutical product, namely, "one code for one product". Using the ESC, manufacturers transmit source information of production and quality, etc. of products to the database of the supervision network; using the ESC, circulation enterprises conduct incoming inspection and acceptance, and transmit the purchase information also to the said database and transmit the sales information to the said database at the time of sales. The data information is provided for consumers to query the authenticity and quality, for government to conduct law enforcement and counterfeit combating, quality tracing, and product recall management, and for enterprises to understand the market supply and demand, channel sales situation, and counterfeit-related information, and achieve the whole-process tracing and flow direction tracking and monitoring of pharmaceutical products.
Narcotic drugs, psychotropic drugs of category I, and APIs in small packages were all included in the electronic supervision from Nov. 1, 2007. Psychotropic drugs of category II, TCM injections, blood products, and vaccines were all included into electronic supervision from Nov. 1, 2008. All varieties of China’s national essential drugs were included into electronic supervision by the end of Feb. 2012.
The former CFDA announced on Jan. 4, 2015, requiring all pharmaceutical preparation manufacturers within China and imported pharmaceutical product manufacturers to be included into China’s pharmaceutical product electronic supervision network by Dec. 31, 2015, and also all pharmaceutical product wholesalers and retailers to be included. With this, all pharmaceutical products in China were all included into the scope of electronic supervision.
However, the former CFDA announced the suspension of the pharmaceutical product electronic supervision and seeking for opinions on the Good Supply Practice for Pharmaceutical Products (GSP) (revised edition) on Feb. 20, 2016 when the pharmaceutical product ESC was comprehensively carried out nationwide. In the revised document, all contents on pharmaceutical product electronic supervision were deleted or modified, and the basic direction was to construct the pharmaceutical product traceability system in the future, to make the information of pharmaceutical product source and whereabouts accessible, and allow liable persons to be held accountable.
The former CFDA issued the Opinions on Promoting Food and Drug Producers and Operators in Improving Traceability Systems in Sep. 2016, specifically mentioning that food and drug producers and operators should take the primary responsibility for the construction of the food and drug traceability system, to make the information of sources and whereabouts of products produced or operated accessible, and encouraging organizations and enterprises at each place to build their traceability systems or purchase pharmaceutical product tracing services of third-party IT enterprises. In 2018 after Changchun Changsheng vaccine incident occurred, the Chinese people were eager to know the vaccine whereabouts and the relevant parties were actively tracking directions of the problematic vaccines, however, there were prominent problems with the pharmaceutical product traceability system, there were no ...
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