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CFDA reclaims the right to operate Ali's health drug electronic regulatory code, open bidding for non-medical IT companies

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2018/09/28 23:16
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According to the latest news from Caixin.com, a person from the State Food and Drug Administration confirmed to Caixin reporter that the State Food and Drug Administration will start a third party to be responsible for the operation of the electronic drug monitoring code, and has clearly reclaimed the agency operation right of Ali, and handed over the work. Expanding.
 
At present, the next specific responsible unit of the electronic drug monitoring code has not yet been determined. According to the person in charge of the State Food and Drug Administration, "a third party should be an enterprise that specializes in IT services, but does not involve medical services, and will implement it through public bidding."
 
In response to the above-mentioned latest announcement, Ali Health told the Caixin reporter that it has not received any notice from the State Food and Drug Administration to stop providing the technical operation and maintenance service of the supervision network.
 
In addition, on the afternoon of February 20, the State Food and Drug Administration issued two consecutive announcements, in view of the implementation of the State Council General Office's "Opinions on Accelerating the Construction of Traceability System for Important Products" (Guo Ban Fa [2015] 95 No.) Requested for public comment on the revision of the electronic regulatory content of the drug in the "Quality Management Standards for Pharmaceutical Products", and now decided to suspend the "Notice on the Relevant Matters Concerning the Full Implementation of Drug Electronic Supervision in Pharmaceutical Production and Management Enterprises by the Food and Drug Administration" (2015) No. 1) Relevant regulations on electronic supervision of drugs. And issued the "Good Manufacturing Practices" (Revised Draft), which is now open to the public for comments. (For details, please refer to the previous issue of "CFDA issued two articles: Suspension of relevant provisions on electronic supervision of drugs, public solicitation of revised GSP terms").
 
Thinking, problem
 
The State Food and Drug Administration has taken back the Ali health agency and suspended the implementation of the relevant provisions on the electronic supervision of drugs in the “Notice on the Full Implementation of Drug Electronic Supervision in Pharmaceutical Production and Operation Enterprises” (No. 1 of 2015), and issued the “Pharmaceutical Management”. The Quality Management Regulations (Revised Draft) undoubtedly shows that the "Xiantian and initiated electronic supervision code litigation incidents" have achieved phased results, and the Ali health that has been questioned has also been understood to some extent, but then there are Several questions have to be considered:
 
1) Is Ali's health loss paid for itself or compensated?
 
As is known to all, at the beginning, Alibaba spent 1.037 billion yuan to control CITIC in the 21st century, which was directed at the electronic code of drug control. After that, Ali Health became famous after relying on the operation of the electronic code of drug control. Hong Kong listed "CITIC 21st Century" It was renamed as “Ali Health”. As of the latest interim report released on November 23, 2015, Ali’s six-month income was HK$21.171 million, almost all from the operation of the drug electronic regulatory code. Once the operation rights of the electronic supervision code are lost, the performance of the stock market is self-evident, which will inevitably lead to the shrinkage of the market value and the loss of a large number of investors.
 
I am afraid that all of this needs to have a clear statement. Perhaps Ali had a similar circumvention clause in the contract for the acquisition of CITIC in the 21st century, but as the government has always emphasized the "market economy", "governing the country according to law", "transparent, open and fair" "It may not be easy for CFDA to make a simple announcement. The twists and turns should be clear, not to make the companies and related personnel involved in the market operate indiscriminately, and to create more insecurity and distrust of the government." Let the government's emphasis on the concept of governance become a joke.
 
Of course, Ali Health will inevitably explain the related issues involved in the relevant announcements.
 
2) After Ali's health is reclaimed, will the company that invested in the early stage or is already operating the electronic supervision code cause losses? If it causes losses, should it be remedied? Who should bear it?
 
3) Due to the monopoly of the exclusive operation of the electronic supervision code, in the previous media reports, Ali health related personnel have the right to rent-seeking and interest-binding, and how should the State Food and Drug Administration supervise the new operators? How to prevent similar events from happening again?
 
(Jilin Qijian Biotechnology Co., Ltd. www.qjbio.com.cn)