Chinese Drug Regulator “Self-defeating” while the U.S. and EU Continuously Strengthening Safety Management of Pharmaceutical Product Supply Chain (2)

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 unified standards for traceability system construction, and there were big loopholes in supervision over pharmaceutical enterprises’ production and circulation processes, making the construction of pharmaceutical product traceability system more urgent.

The National Medical Products Administration of China (NMPA) issued the Guiding Opinions on Building Information Technology-Enabled Drug Traceability Systems (Draft for Comment) on Aug. 24, 2018; the new edition GSP specifically proposes that the traceability systems should cover each link of the procurement, storage, sales, and transport, therefore, for the possible quality safety problems in each link of pharmaceutical products from production, circulation, to consumption and use, the pharmaceutical product traceability systems should make the information of source and whereabouts accessible and allow liable persons to be held accountable which, from the professional perspective, scientific perspective, and information perspective, requires close cooperation and diversified technology and information support.

With regard to the above regulation documents, it seems that China’s drug regulator NMPA does not give up the regulatory duties and has put forward clear requirements for pharmaceutical production and circulation enterprises, however, in fact, before the ESC was abolished, there had already been an electronic supervision system envied by the EU and U.S. markets, which was established under the leadership of the former CFDA, with cooperation and coordination from the provincial administrations and substantial funds spent by Chinese enterprises (including import enterprises) at the urging thereof. And the only drawback was that the pharmaceutical product circulation data were not on public servers but managed by Alibaba. Despite this, such electronic supervision system was still leading and comprehensive, and was an essential weapon for pharmaceutical product circulation, returns handling, and pharmaceutical product recall. And what happened then? The former CFDA abolished what had been built for over 10 years through an official document simply because of concerns and doubts of pharmaceutical enterprises about the security of circulation data.

According to the current regulations, production and circulation enterprises should take charge of establishing such system, however, this is practically impossible. Apart from the funds and energy required for establishing a huge pharmaceutical product traceability system, the uncooperative attitude of downstream distributors alone will leave manufacturers at disadvantage in the market helpless. Therefore, don’t ever think that the market is omnipotent and can decide everything.

Seeing the EU and U.S. continue to strengthen their pharmaceutical product circulation traceability systems, Chinese pharmaceutical practitioners have no other way but to wait in silence…

Related:

Chinese Drug Regulator "Self-defeating" while the U.S. and EU Continuously Strengthening Safety Management of Pharmaceutical Product Supply Chain (1)

About the Author:

zhulikou431

Zhulikou431, as a senior engineer, PDA member, ISPE member, ECA member, PQRI member, senior aseptic GMP expert, has deep knowledge in aseptic process development and verification, drug development and registration, CTD document writing and review, regulatory audit, international certification, international registration , quality system construction and maintenance, as well as sterile inspection, environmental monitoring and other fields. In recent years, he has focused on the analysis of trends in the macro pharmaceutical field and the risk management of pharmaceutical enterprise mergers and acquisitions projects.

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